Trial Outcomes & Findings for A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D) (NCT NCT03751007)
NCT ID: NCT03751007
Last Updated: 2023-02-01
Results Overview
Treatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab
COMPLETED
PHASE1/PHASE2
45 participants
up to 6 months
2023-02-01
Participant Flow
AG019 monotherapy cohorts: a total of 8 single dose patients and 19 repeat dose patients. AG019/teplizumab combination cohorts: a total of 18 patients
* 18-40y, or 12-17y * diagnosis of diabetes according to ADA criteria * positive for at least 1 T1D autoantibody * treatment to be started within 150 days of diagnosis * greater than 0.2 nmol/L of C-peptide following mixed meal tolerance test * No active infections
Participant milestones
| Measure |
AG019 Cohort 1 - Low (Single) Dose/Adults
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 1 - Low (Repeat) Dose/Adults
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 2 - High (Single) Dose/Adults
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 2 - High (Repeat) Dose/Adults
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 3 - Low (Single) Dose/Adolescents
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 4 - High (Single) Dose/Adolescents
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 4 - High (Repeat) Dose/Adolescents
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
Combination Cohort 1 - Active AG019/Teplizumab - Adults
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks.
|
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks.
|
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
2
|
5
|
2
|
4
|
2
|
5
|
10
|
2
|
5
|
1
|
|
Overall Study
COMPLETED
|
2
|
5
|
2
|
4
|
2
|
4
|
2
|
4
|
10
|
2
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
this assessment was not required for single dose patients, result not available
Baseline characteristics by cohort
| Measure |
AG019 Cohort 1 - Low (Single) Dose/Adults
n=2 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 1 - Low (Repeat) Dose/Adults
n=5 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 2 - High (Single) Dose/Adults
n=2 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 2 - High (Repeat) Dose/Adults
n=5 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 3 - Low (Single) Dose/Adolescents
n=2 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents
n=4 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 4 - High (Single) Dose/Adolescents
n=2 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 4 - High (Repeat) Dose/Adolescents
n=5 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
Combination Cohort 1 - Active AG019/Teplizumab - Adults
n=10 Participants
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks
|
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults
n=2 Participants
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents
n=5 Participants
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks
|
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents
n=1 Participants
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 5.7 • n=2 Participants
|
26.0 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
19.5 years
STANDARD_DEVIATION 2.1 • n=2 Participants
|
22.0 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
16.5 years
STANDARD_DEVIATION 0.7 • n=2 Participants
|
14.0 years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
17.0 years
STANDARD_DEVIATION 0.0 • n=2 Participants
|
14.0 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
26.5 years
STANDARD_DEVIATION 6.7 • n=10 Participants
|
29.0 years
STANDARD_DEVIATION 5.7 • n=2 Participants
|
14.0 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
12.0 years
STANDARD_DEVIATION 0.0 • n=1 Participants
|
20.0 years
STANDARD_DEVIATION 8.6 • n=45 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
20 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
25 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
42 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=45 Participants
|
|
Baseline serological cytomegalovirus positivity
Negative
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
37 Participants
n=45 Participants
|
|
Baseline serological cytomegalovirus positivity
Positive
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
7 Participants
n=45 Participants
|
|
Baseline serological cytomegalovirus positivity
Missing
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=45 Participants
|
|
Baseline serological Epstein-Barr virus positivity
Negative
|
2 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
31 Participants
n=45 Participants
|
|
Baseline serological Epstein-Barr virus positivity
Positive
|
0 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
14 Participants
n=45 Participants
|
|
Autoantibody positivity - GAD65
Negative
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=45 Participants
|
|
Autoantibody positivity - GAD65
Positive
|
1 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
39 Participants
n=45 Participants
|
|
Autoantibody positivity - GAD65
Missing
|
1 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=45 Participants
|
|
Autoantibody positivity - IA-2
Negative
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
16 Participants
n=45 Participants
|
|
Autoantibody positivity - IA-2
Positive
|
0 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
21 Participants
n=45 Participants
|
|
Autoantibody positivity - IA-2
Missing
|
1 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
8 Participants
n=45 Participants
|
|
Autoantibody positivity - ZnT8
Negative
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
7 Participants
n=45 Participants
|
|
Autoantibody positivity - ZnT8
Positive
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
20 Participants
n=45 Participants
|
|
Autoantibody positivity - ZnT8
Missing
|
1 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
18 Participants
n=45 Participants
|
|
Autoantibody positivity - Insulin
Negative
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
19 Participants
n=45 Participants
|
|
Autoantibody positivity - Insulin
Positive
|
0 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
13 Participants
n=45 Participants
|
|
Autoantibody positivity - Insulin
Missing
|
1 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
13 Participants
n=45 Participants
|
|
Insulin required at baseline
Yes
|
1 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
43 Participants
n=45 Participants
|
|
Insulin required at baseline
No
|
1 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=45 Participants
|
|
Baseline HbA1c
|
—
|
6.38 percent
STANDARD_DEVIATION 0.56 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
7.00 percent
STANDARD_DEVIATION 1.57 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
6.40 percent
STANDARD_DEVIATION 0.51 • n=4 Participants • this assessment was not required for single dose patients, result not available
|
—
|
6.28 percent
STANDARD_DEVIATION 0.89 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
6.92 percent
STANDARD_DEVIATION 1.42 • n=10 Participants • this assessment was not required for single dose patients, result not available
|
7.35 percent
STANDARD_DEVIATION 3.04 • n=2 Participants • this assessment was not required for single dose patients, result not available
|
7.14 percent
STANDARD_DEVIATION 2.43 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
8.40 percent
n=1 Participants • this assessment was not required for single dose patients, result not available
|
6.86 percent
STANDARD_DEVIATION 1.44 • n=37 Participants • this assessment was not required for single dose patients, result not available
|
|
Time from diagnosis to treatment
|
84.5 days
STANDARD_DEVIATION 44.5 • n=2 Participants
|
91.0 days
STANDARD_DEVIATION 38.2 • n=5 Participants
|
45.5 days
STANDARD_DEVIATION 20.5 • n=2 Participants
|
100 days
STANDARD_DEVIATION 42.2 • n=5 Participants
|
146.0 days
STANDARD_DEVIATION 4.2 • n=2 Participants
|
95.0 days
STANDARD_DEVIATION 21.3 • n=4 Participants
|
113.0 days
STANDARD_DEVIATION 53.7 • n=2 Participants
|
126.4 days
STANDARD_DEVIATION 19.4 • n=5 Participants
|
101.0 days
STANDARD_DEVIATION 35.9 • n=10 Participants
|
70.0 days
STANDARD_DEVIATION 15.6 • n=2 Participants
|
122.6 days
STANDARD_DEVIATION 36.3 • n=5 Participants
|
90.0 days
n=1 Participants
|
102.2 days
STANDARD_DEVIATION 36.1 • n=45 Participants
|
|
Baseline IDAA1c
|
—
|
7.385 units on a scale'
STANDARD_DEVIATION 1.303 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
8.248 units on a scale'
STANDARD_DEVIATION 2.369 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
9.090 units on a scale'
STANDARD_DEVIATION 1.093 • n=4 Participants • this assessment was not required for single dose patients, result not available
|
—
|
8.392 units on a scale'
STANDARD_DEVIATION 2.470 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
8.412 units on a scale'
STANDARD_DEVIATION 1.725 • n=10 Participants • this assessment was not required for single dose patients, result not available
|
8.530 units on a scale'
STANDARD_DEVIATION 4.540 • n=2 Participants • this assessment was not required for single dose patients, result not available
|
9.605 units on a scale'
STANDARD_DEVIATION 2.583 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
10.640 units on a scale'
n=1 Participants • this assessment was not required for single dose patients, result not available
|
8.55 units on a scale'
STANDARD_DEVIATION 2.02 • n=37 Participants • this assessment was not required for single dose patients, result not available
|
|
Fasting C-peptide
|
—
|
0.27 nmol/L
STANDARD_DEVIATION 0.15 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.38 nmol/L
STANDARD_DEVIATION 0.19 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.33 nmol/L
STANDARD_DEVIATION 0.08 • n=4 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.27 nmol/L
STANDARD_DEVIATION 0.14 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
0.18 nmol/L
STANDARD_DEVIATION 0.13 • n=10 Participants • this assessment was not required for single dose patients, result not available
|
0.36 nmol/L
STANDARD_DEVIATION 0.22 • n=2 Participants • this assessment was not required for single dose patients, result not available
|
0.25 nmol/L
STANDARD_DEVIATION 0.07 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
0.16 nmol/L
n=1 Participants • this assessment was not required for single dose patients, result not available
|
0.65 nmol/L
STANDARD_DEVIATION 0.46 • n=37 Participants • this assessment was not required for single dose patients, result not available
|
|
Peak stimulated C-peptide
|
—
|
0.92 nmol/L
STANDARD_DEVIATION 0.35 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
1.26 nmol/L
STANDARD_DEVIATION 1.12 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.97 nmol/L
STANDARD_DEVIATION 0.45 • n=4 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.81 nmol/L
STANDARD_DEVIATION 0.09 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
0.71 nmol/L
STANDARD_DEVIATION 0.26 • n=10 Participants • this assessment was not required for single dose patients, result not available
|
1.10 nmol/L
STANDARD_DEVIATION 0.11 • n=2 Participants • this assessment was not required for single dose patients, result not available
|
0.76 nmol/L
STANDARD_DEVIATION 0.25 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
0.28 nmol/L
n=1 Participants • this assessment was not required for single dose patients, result not available
|
2.08 nmol/L
STANDARD_DEVIATION 1.54 • n=37 Participants • this assessment was not required for single dose patients, result not available
|
|
Mean 2H C-peptide AUC
|
—
|
0.418 nmol/L
STANDARD_DEVIATION 0.257 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.500 nmol/L
STANDARD_DEVIATION 0.327 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.428 nmol/L
STANDARD_DEVIATION 0.134 • n=4 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.512 nmol/L
STANDARD_DEVIATION 0.484 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
0.464 nmol/L
STANDARD_DEVIATION 0.255 • n=10 Participants • this assessment was not required for single dose patients, result not available
|
0.396 nmol/L
STANDARD_DEVIATION 0.000 • n=2 Participants • this assessment was not required for single dose patients, result not available
|
0.665 nmol/L
STANDARD_DEVIATION 0.160 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
0.000 nmol/L
STANDARD_DEVIATION 0.000 • n=1 Participants • this assessment was not required for single dose patients, result not available
|
0.63 nmol/L
STANDARD_DEVIATION 0.32 • n=37 Participants • this assessment was not required for single dose patients, result not available
|
|
Total daily insulin use
|
—
|
0.23 IU/kg/d
STANDARD_DEVIATION 0.18 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.39 IU/kg/d
STANDARD_DEVIATION 0.20 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.67 IU/kg/d
STANDARD_DEVIATION 0.27 • n=4 Participants • this assessment was not required for single dose patients, result not available
|
—
|
0.53 IU/kg/d
STANDARD_DEVIATION 0.46 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
0.37 IU/kg/d
STANDARD_DEVIATION 0.14 • n=10 Participants • this assessment was not required for single dose patients, result not available
|
0.30 IU/kg/d
STANDARD_DEVIATION 0.37 • n=2 Participants • this assessment was not required for single dose patients, result not available
|
0.51 IU/kg/d
STANDARD_DEVIATION 0.18 • n=5 Participants • this assessment was not required for single dose patients, result not available
|
0.56 IU/kg/d
n=1 Participants • this assessment was not required for single dose patients, result not available
|
0.42 IU/kg/d
STANDARD_DEVIATION 0.27 • n=37 Participants • this assessment was not required for single dose patients, result not available
|
PRIMARY outcome
Timeframe: up to 6 monthsTreatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab
Outcome measures
| Measure |
AG019 Cohort 1 - Low (Single) Dose/Adults
n=2 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 1 - Low (Repeat) Dose/Adults
n=5 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 2 - High (Single) Dose/Adults
n=2 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 2 - High (Repeat) Dose/Adults
n=5 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 3 - Low (Single) Dose/Adolescents
n=2 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents
n=4 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 4 - High (Single) Dose/Adolescents
n=2 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 4 - High (Repeat) Dose/Adolescents
n=5 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
Combination Cohort 1 - Active AG019/Teplizumab - Adults
n=10 Participants
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults
n=2 Participants
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents
n=5 Participants
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents
n=1 Participants
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAE)
|
1 Events
|
6 Events
|
1 Events
|
19 Events
|
1 Events
|
28 Events
|
1 Events
|
19 Events
|
91 Events
|
25 Events
|
22 Events
|
1 Events
|
SECONDARY outcome
Timeframe: Up to 3 months after initiation of the treatmentPopulation: This assessment was not required for single dose patients, result not available
The presence of live L. lactis bacteria in blood will be assessed by plating
Outcome measures
| Measure |
AG019 Cohort 1 - Low (Single) Dose/Adults
n=5 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 1 - Low (Repeat) Dose/Adults
n=5 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 2 - High (Single) Dose/Adults
n=4 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 2 - High (Repeat) Dose/Adults
n=5 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 3 - Low (Single) Dose/Adolescents
n=10 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents
n=2 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 4 - High (Single) Dose/Adolescents
n=4 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 4 - High (Repeat) Dose/Adolescents
n=1 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
Combination Cohort 1 - Active AG019/Teplizumab - Adults
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AG019 in Systemic Circulation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months after initiation of the treatmentPopulation: Indication for exposure of AG019 secreted hPINS or hIL-10 protein in plasma This assessment was not required for single dose patients, result not available
The presence of L. lactis-secreted hPINS or hIL-10 in the blood will be assessed by ELISA (enzyme-linked immunosorbent assay)
Outcome measures
| Measure |
AG019 Cohort 1 - Low (Single) Dose/Adults
n=5 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 1 - Low (Repeat) Dose/Adults
n=5 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 2 - High (Single) Dose/Adults
n=4 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 2 - High (Repeat) Dose/Adults
n=5 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 3 - Low (Single) Dose/Adolescents
n=10 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents
n=2 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 4 - High (Single) Dose/Adolescents
n=4 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 4 - High (Repeat) Dose/Adolescents
n=1 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
Combination Cohort 1 - Active AG019/Teplizumab - Adults
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
L. Lactis-secreted hPINS or hIL-10 in Systemic Circulation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 days after completion of the treatmentPopulation: This assessment was not required for single dose patients, result not available
The presence of L. lactis (live or dead) in feces will be assessed by Q-PCR (quantitative real-time polymerase chain reaction)
Outcome measures
| Measure |
AG019 Cohort 1 - Low (Single) Dose/Adults
n=5 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 1 - Low (Repeat) Dose/Adults
n=4 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 2 - High (Single) Dose/Adults
n=10 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 2 - High (Repeat) Dose/Adults
n=2 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 3 - Low (Single) Dose/Adolescents
n=3 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents
n=1 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 4 - High (Single) Dose/Adolescents
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 4 - High (Repeat) Dose/Adolescents
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
Combination Cohort 1 - Active AG019/Teplizumab - Adults
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AG019 in Feces
participants with no AG019 in feces
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AG019 in Feces
participants with AG019 in feces
|
3 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 monthsMMTT-stimulated 2-hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 2-hour period divided by the duration after a mixed-meal tolerance test.
Outcome measures
| Measure |
AG019 Cohort 1 - Low (Single) Dose/Adults
n=5 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 1 - Low (Repeat) Dose/Adults
n=5 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 2 - High (Single) Dose/Adults
n=10 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 2 - High (Repeat) Dose/Adults
n=2 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 3 - Low (Single) Dose/Adolescents
n=5 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents
n=1 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 4 - High (Single) Dose/Adolescents
n=5 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 4 - High (Repeat) Dose/Adolescents
n=4 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
Combination Cohort 1 - Active AG019/Teplizumab - Adults
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 2 Hour Mixed Meal Tolerance Test (MMTT) at 12 Months
|
0.89 nmol/L
Standard Deviation 0.61
|
0.57 nmol/L
Standard Deviation 0.13
|
0.48 nmol/L
Standard Deviation 0.19
|
0.73 nmol/L
Standard Deviation 0.01
|
0.57 nmol/L
Standard Deviation 0.21
|
0.25 nmol/L
Standard Deviation 0
|
0.62 nmol/L
Standard Deviation 0.48
|
0.78 nmol/L
Standard Deviation 0.35
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 months from screeningIncidence of all reported TEAE up to the 12-month follow-up visit. The TEAE are counted once within each patient on the preferred term level.
Outcome measures
| Measure |
AG019 Cohort 1 - Low (Single) Dose/Adults
n=2 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 1 - Low (Repeat) Dose/Adults
n=2 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 2 - High (Single) Dose/Adults
n=2 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 2 - High (Repeat) Dose/Adults
n=5 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 3 - Low (Single) Dose/Adolescents
n=2 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents
n=4 Participants
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 4 - High (Single) Dose/Adolescents
n=2 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 4 - High (Repeat) Dose/Adolescents
n=5 Participants
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
Combination Cohort 1 - Active AG019/Teplizumab - Adults
n=10 Participants
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults
n=2 Participants
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents
n=5 Participants
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents
n=1 Participants
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events up to 12 Months
|
1 events
|
8 events
|
1 events
|
26 events
|
1 events
|
33 events
|
1 events
|
26 events
|
97 events
|
26 events
|
23 events
|
2 events
|
Adverse Events
AG019 Cohort 1 - Low (Single) Dose/Adults
AG019 Cohort 1 - Low (Repeat) Dose/Adults
AG019 Cohort 2 - High (Single) Dose/Adults
AG019 Cohort 2 - High (Repeat) Dose/Adults
AG019 Cohort 3 - Low (Single) Dose/Adolescents
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents
AG019 Cohort 4 - High (Single) Dose/Adolescents
AG019 Cohort 4 - High (Repeat) Dose/Adolescents
Combination Cohort 1 - Active AG019/Teplizumab - Adults
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AG019 Cohort 1 - Low (Single) Dose/Adults
n=2 participants at risk
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 1 - Low (Repeat) Dose/Adults
n=5 participants at risk
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 2 - High (Single) Dose/Adults
n=2 participants at risk
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 2 - High (Repeat) Dose/Adults
n=5 participants at risk
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 3 - Low (Single) Dose/Adolescents
n=2 participants at risk
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)
|
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents
n=4 participants at risk
AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)
|
AG019 Cohort 4 - High (Single) Dose/Adolescents
n=2 participants at risk
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)
|
AG019 Cohort 4 - High (Repeat) Dose/Adolescents
n=5 participants at risk
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)
|
Combination Cohort 1 - Active AG019/Teplizumab - Adults
n=10 participants at risk
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults
n=2 participants at risk
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents
n=5 participants at risk
Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).
|
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents
n=1 participants at risk
Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Blood and lymphatic system disorders
Erythropenia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
100.0%
2/2 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
2/4 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 6 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
30.0%
3/10 • Number of events 5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Eye disorders
Retinopathy
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
4/10 • Number of events 4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
4/10 • Number of events 4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Tongue dry
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
4/10 • Number of events 12 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Administration site pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Catheter site pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Catheter site pruritus
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Chest pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Chills
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Infusion site irritation
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Immune system disorders
Selective IgA immunodeficiency
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Body tinea
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
30.0%
3/10 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Blood potassium increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Blood urea increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Body Temperature decreased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Epstein-Barr virus test positive
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Platelet count increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Protein total increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
Weight increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 8 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
5/10 • Number of events 7 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
100.0%
2/2 • Number of events 11 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Reproductive system and breast disorders
Scrotal irritation
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
2/10 • Number of events 6 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
50.0%
5/10 • Number of events 5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Vascular disorders
Pallor
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/4 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
|
Investigations
haemoglobin increased
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/10 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/2 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/5 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
0.00%
0/1 • Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).
All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidentiality and consulting agreements restrict the dissemination of confidential information, but PIs are not restricted to act as a consultant for other companies.
- Publication restrictions are in place
Restriction type: OTHER