Trial Outcomes & Findings for Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D (NCT NCT03920007)
NCT ID: NCT03920007
Last Updated: 2026-08-03
Results Overview
Number of participants with treatment-emergent AEs will be summarized in each cohort (this includes cohorts 1 - 5)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
From Baseline to Week 52
Results posted on
2026-08-03
Participant Flow
Study screening and enrollment occurred between October 2019 through May 2022. A total of 23 patients were screened, resulting in 2 enrollments at the Casey Eye Institute - Oregon Health and Science University and 13 enrollments at the Scheie Eye Institute - University of Pennsylvania to reach the study's goal of 15 enrolled patients across all cohorts.
Of the 23 screened patients, 15 had a signed ICF and were not identified as screen failures and were assigned to single dose of ATSN-101 in the dose escalation and dose expansion phases of the study (Cohorts 1-5). Participants are still ongoing in the study From Week 52 to Week 260. The record will be updated upon study completion.
Unit of analysis: eye
Participant milestones
| Measure |
ATSN-101 Cohort 1
ATSN-101 single dose of 1.0x10\^10 vg/eye.
|
ATSN-101 Cohort 2
ATSN-101 single dose of 3.0x10\^10 vg/eye.
|
ATSN-101 Cohort 3
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 4 (Adult Expansion)
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 5 (Pediatric Expansion)
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
|---|---|---|---|---|---|
|
Enrollment to Week 52
STARTED
|
3 3
|
3 3
|
3 3
|
3 3
|
3 3
|
|
Enrollment to Week 52
COMPLETED
|
3 3
|
3 3
|
3 3
|
3 3
|
3 3
|
|
Enrollment to Week 52
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Enrollment to Week 260
STARTED
|
3 3
|
3 3
|
3 3
|
3 3
|
3 3
|
|
Enrollment to Week 260
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Enrollment to Week 260
NOT COMPLETED
|
3 3
|
3 3
|
3 3
|
3 3
|
3 3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Population: Includes all Screened Population participants who received study treatment.
Baseline characteristics by cohort
| Measure |
ATSN-101 Cohort 1
n=3 Participants
ATSN-101 single dose of 1.0x10\^10 vg/eye.
|
ATSN-101 Cohort 2
n=3 Participants
ATSN-101 single dose of 3.0x10\^10 vg/eye.
|
ATSN-101 Cohort 3
n=3 Participants
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 4 (Adult Expansion)
n=3 Participants
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 5 (Pediatric Expansion)
n=3 Participants
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.7 Years
STANDARD_DEVIATION 11.06 • n=20 Participants • Safety Population: Includes all Screened Population participants who received study treatment.
|
23.3 Years
STANDARD_DEVIATION 7.57 • n=20 Participants • Safety Population: Includes all Screened Population participants who received study treatment.
|
23.7 Years
STANDARD_DEVIATION 7.37 • n=40 Participants • Safety Population: Includes all Screened Population participants who received study treatment.
|
39.0 Years
STANDARD_DEVIATION 32.08 • n=6 Participants • Safety Population: Includes all Screened Population participants who received study treatment.
|
14.0 Years
STANDARD_DEVIATION 1.73 • n=7 Participants • Safety Population: Includes all Screened Population participants who received study treatment.
|
26.7 Years
STANDARD_DEVIATION 16.21 • n=13 Participants • Safety Population: Includes all Screened Population participants who received study treatment.
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Ethnicity
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=13 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=13 Participants
|
|
Ethnicity
Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Ethnicity
Unknown
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Baseline Height (cm)
|
165.0 cm
STANDARD_DEVIATION 11.27 • n=20 Participants
|
174.7 cm
STANDARD_DEVIATION 7.57 • n=20 Participants
|
165.7 cm
STANDARD_DEVIATION 1.15 • n=40 Participants
|
163.7 cm
STANDARD_DEVIATION 8.33 • n=6 Participants
|
158.0 cm
STANDARD_DEVIATION 10.15 • n=7 Participants
|
165.4 cm
STANDARD_DEVIATION 9.05 • n=13 Participants
|
|
Baseline Weight (kg)
|
77.9 kg
STANDARD_DEVIATION 26.29 • n=20 Participants
|
69.3 kg
STANDARD_DEVIATION 15.61 • n=20 Participants
|
60.5 kg
STANDARD_DEVIATION 11.03 • n=40 Participants
|
65.7 kg
STANDARD_DEVIATION 18.34 • n=6 Participants
|
54.5 kg
STANDARD_DEVIATION 1.46 • n=7 Participants
|
65.6 kg
STANDARD_DEVIATION 16.32 • n=13 Participants
|
|
Baseline BMI (kg/m^2)
|
28.0 kg/m^2
STANDARD_DEVIATION 5.44 • n=20 Participants
|
22.6 kg/m^2
STANDARD_DEVIATION 3.94 • n=20 Participants
|
22.0 kg/m^2
STANDARD_DEVIATION 3.70 • n=40 Participants
|
24.4 kg/m^2
STANDARD_DEVIATION 5.69 • n=6 Participants
|
22.1 kg/m^2
STANDARD_DEVIATION 3.50 • n=7 Participants
|
23.8 kg/m^2
STANDARD_DEVIATION 4.51 • n=13 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 52Population: Safety Population: Includes all Screened Population participants who received study treatment.
Number of participants with treatment-emergent AEs will be summarized in each cohort (this includes cohorts 1 - 5)
Outcome measures
| Measure |
ATSN-101 Cohort 1
n=3 Participants
ATSN-101 single dose of 1.0x10\^10 vg/eye.
|
ATSN-101 Cohort 2
n=3 Participants
ATSN-101 single dose of 3.0x10\^10 vg/eye.
|
ATSN-101 Cohort 3
n=3 Participants
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 4 (Adult Expansion)
n=3 Participants
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 5 (Pediatric Expansion)
n=3 Participants
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) From Baseline up to the End of the Observation Period
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Population represents the following: Cohort 1 is 1.0x10\^10 vg/eye. Cohort 2 is 3.0x10\^10 vg/eye. Cohort 3 is 1.0x10\^11 vg/eye. Cohort 4 is 1.0x10\^11 vg/eye. Cohort 5 is 1.0x10\^11 vg/eye. High Dose includes participants from Cohorts 3, 4, and 5. Population consists of all participants who signed the informed consent, received study treatment, and have evaluable data at Baseline and Week 52. One participant in Cohort 3 was excluded from the analysis due to missing the Week 52 visit.
Mean change from Baseline to Week 52 in BCVA (LogMAR) in the treated eye and untreated eye (control). In logMAR notation (logarithm of the minimum angle of resolution) is interpreted as follows: Lower LogMAR values indicates better vision. Higher LogMAR values indicates worse vision.
Outcome measures
| Measure |
ATSN-101 Cohort 1
n=14 eye
ATSN-101 single dose of 1.0x10\^10 vg/eye.
|
ATSN-101 Cohort 2
n=14 eye
ATSN-101 single dose of 3.0x10\^10 vg/eye.
|
ATSN-101 Cohort 3
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 4 (Adult Expansion)
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 5 (Pediatric Expansion)
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
|---|---|---|---|---|---|
|
Change From Baseline of Best-Corrected Visual Acuity (BCVA) Between the Treated and Untreated Eyes
ATSN-101 Cohort 1
|
-0.27 LogMAR
Standard Deviation 0.30
|
-0.19 LogMAR
Standard Deviation 0.35
|
—
|
—
|
—
|
|
Change From Baseline of Best-Corrected Visual Acuity (BCVA) Between the Treated and Untreated Eyes
ATSN-101 Cohort 2
|
-0.08 LogMAR
Standard Deviation 0.09
|
-0.04 LogMAR
Standard Deviation 0.04
|
—
|
—
|
—
|
|
Change From Baseline of Best-Corrected Visual Acuity (BCVA) Between the Treated and Untreated Eyes
ATSN-101 Cohort 3
|
-0.37 LogMAR
Standard Deviation 0.47
|
0.00 LogMAR
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline of Best-Corrected Visual Acuity (BCVA) Between the Treated and Untreated Eyes
ATSN-101 Cohort 4 (Adult Expansion)
|
-0.12 LogMAR
Standard Deviation 0.11
|
0.03 LogMAR
Standard Deviation 0.03
|
—
|
—
|
—
|
|
Change From Baseline of Best-Corrected Visual Acuity (BCVA) Between the Treated and Untreated Eyes
ATSN-101 Cohort 5 (Pediatric Expansion)
|
-0.05 LogMAR
Standard Deviation 0.18
|
-0.01 LogMAR
Standard Deviation 0.02
|
—
|
—
|
—
|
|
Change From Baseline of Best-Corrected Visual Acuity (BCVA) Between the Treated and Untreated Eyes
ATSN-101 High Dose
|
-0.16 LogMAR
Standard Deviation 0.25
|
0.01 LogMAR
Standard Deviation 0.03
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Population represents the following: Cohort 1 is 1.0x10\^10 vg/eye. Cohort 2 is 3.0x10\^10 vg/eye. Cohort 3 is 1.0x10\^11 vg/eye. Cohort 4 is 1.0x10\^11 vg/eye. Cohort 5 is 1.0x10\^11 vg/eye. High Dose includes participants from Cohorts 3, 4, and 5. Population consists of all participants who signed the informed consent, received study treatment, and have evaluable data at Baseline and Week 52. One participant in Cohort 3 was excluded from the analysis due to missing the Week 52 visit.
Mean change from Baseline to Week 52 in sensitivity as measured by the full-field stimulus testing - Light Adapted in the treated eye and untreated eye. Full-field stimulus testing was performed for three stimulus colors - blue, red, and white.
Outcome measures
| Measure |
ATSN-101 Cohort 1
n=14 eye
ATSN-101 single dose of 1.0x10\^10 vg/eye.
|
ATSN-101 Cohort 2
n=14 eye
ATSN-101 single dose of 3.0x10\^10 vg/eye.
|
ATSN-101 Cohort 3
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 4 (Adult Expansion)
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 5 (Pediatric Expansion)
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
|---|---|---|---|---|---|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 1 - Blue
|
0.81 dB
Standard Deviation 3.09
|
-1.11 dB
Standard Deviation 3.10
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 2 - Blue
|
1.44 dB
Standard Deviation 3.10
|
3.14 dB
Standard Deviation 4.21
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 3 - Blue
|
1.00 dB
Standard Deviation 0.94
|
4.83 dB
Standard Deviation 2.12
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 4 (Adult Expansion) - Blue
|
-0.87 dB
Standard Deviation 6.09
|
-1.51 dB
Standard Deviation 3.74
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 5 (Pediatric Expansion) - Blue
|
5.53 dB
Standard Deviation 14.29
|
6.92 dB
Standard Deviation 10.31
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 High Dose - Blue
|
2.00 dB
Standard Deviation 8.84
|
3.24 dB
Standard Deviation 7.15
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 1 - Red
|
2.06 dB
Standard Deviation 2.71
|
0.78 dB
Standard Deviation 2.04
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 2 - Red
|
3.12 dB
Standard Deviation 5.72
|
1.71 dB
Standard Deviation 2.89
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 3 - Red
|
14.20 dB
Standard Deviation 1.90
|
6.67 dB
Standard Deviation 5.66
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 4 (Adult Expansion) - Red
|
2.67 dB
Standard Deviation 2.36
|
-0.17 dB
Standard Deviation 4.01
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 5 (Pediatric Expansion) - Red
|
-3.67 dB
Standard Deviation 0.47
|
0.17 dB
Standard Deviation 2.59
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 High Dose - Red
|
4.40 dB
Standard Deviation 8.22
|
2.22 dB
Standard Deviation 4.78
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 1 - White
|
1.13 dB
Standard Deviation 2.80
|
1.67 dB
Standard Deviation 3.33
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 2 - White
|
1.70 dB
Standard Deviation 2.52
|
0.90 dB
Standard Deviation 3.73
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 3 - White
|
2.50 dB
Standard Deviation 1.41
|
3.00 dB
Standard Deviation 3.54
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 4 (Adult Expansion) - White
|
3.10 dB
Standard Deviation 4.00
|
0.32 dB
Standard Deviation 1.74
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 Cohort 5 (Pediatric Expansion) - White
|
4.60 dB
Standard Deviation 13.87
|
-2.00 dB
Standard Deviation 4.24
|
—
|
—
|
—
|
|
Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Light Adapted
ATSN-101 High Dose - White
|
3.51 dB
Standard Deviation 7.79
|
0.42 dB
Standard Deviation 3.20
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Population represents the following: Cohort 1 is 1.0x10\^10 vg/eye. Cohort 2 is 3.0x10\^10 vg/eye. Cohort 3 is 1.0x10\^11 vg/eye. Cohort 4 is 1.0x10\^11 vg/eye. Cohort 5 is 1.0x10\^11 vg/eye. High Dose includes participants from Cohorts 3, 4, and 5. Population consists of all participants who signed the informed consent, received study treatment, and have evaluable data at Baseline and Week 52. One participant in Cohort 3 was excluded from the analysis due to missing the Week 52 visit.
Mean change from Baseline to Week 52 in sensitivity as measured by the full-field stimulus testing - Dark Adapted in the treated eye and untreated eye. Full-field stimulus testing was performed for three stimulus colors - blue, red, and white.
Outcome measures
| Measure |
ATSN-101 Cohort 1
n=14 eye
ATSN-101 single dose of 1.0x10\^10 vg/eye.
|
ATSN-101 Cohort 2
n=14 eye
ATSN-101 single dose of 3.0x10\^10 vg/eye.
|
ATSN-101 Cohort 3
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 4 (Adult Expansion)
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 5 (Pediatric Expansion)
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 1 - Blue
|
6.89 dB
Standard Deviation 6.19
|
2.78 dB
Standard Deviation 3.91
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 2 - Blue
|
2.11 dB
Standard Deviation 3.34
|
-0.78 dB
Standard Deviation 3.10
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 3 - Blue
|
29.92 dB
Standard Deviation 11.67
|
-2.49 dB
Standard Deviation 1.63
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 4 (Adult Expansion) - Blue
|
25.53 dB
Standard Deviation 21.88
|
1.60 dB
Standard Deviation 6.57
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 5 (Pediatric Expansion) - Blue
|
6.54 dB
Standard Deviation 5.95
|
2.59 dB
Standard Deviation 6.27
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 High Dose - Blue
|
21.36 dB
Standard Deviation 17.16
|
0.95 dB
Standard Deviation 5.35
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 1 - Red
|
6.22 dB
Standard Deviation 6.05
|
1.33 dB
Standard Deviation 1.76
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 2 - Red
|
3.33 dB
Standard Deviation 9.43
|
-4.00 dB
Standard Deviation 3.77
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 3 - Red
|
28.67 dB
Standard Deviation 14.61
|
0.17 dB
Standard Deviation 4.01
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 4 (Adult Expansion) - Red
|
18.49 dB
Standard Deviation 11.16
|
2.89 dB
Standard Deviation 4.73
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 5 (Pediatric Expansion) - Red
|
12.18 dB
Standard Deviation 10.97
|
-3.69 dB
Standard Deviation 15.73
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 High Dose - Red
|
18.67 dB
Standard Deviation 12.13
|
-0.26 dB
Standard Deviation 9.42
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 1 - White
|
5.37 dB
Standard Deviation 7.16
|
1.22 dB
Standard Deviation 2.91
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 2 - White
|
0.89 dB
Standard Deviation 5.50
|
-0.78 dB
Standard Deviation 7.30
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 3 - White
|
28.50 dB
Standard Deviation 21.21
|
-2.00 dB
Standard Deviation 4.95
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 4 (Adult Expansion) - White
|
24.94 dB
Standard Deviation 20.18
|
1.04 dB
Standard Deviation 5.13
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 Cohort 5 (Pediatric Expansion) - White
|
7.17 dB
Standard Deviation 6.60
|
4.20 dB
Standard Deviation 6.65
|
—
|
—
|
—
|
|
Mean Change From Baseline of Sensitivity Between the Treated and Untreated Eye - Dark Adapted
ATSN-101 High Dose - White
|
20.88 dB
Standard Deviation 17.56
|
1.08 dB
Standard Deviation 5.16
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 260Number of participants with treatment-emergent AEs will be summarized in each cohort (this includes cohorts 1 - 5)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 260Mean change from Baseline to Week 260 in BCVA (LogMAR) in the treated eye and untreated eye (control). In logMAR notation (logarithm of the minimum angle of resolution) is interpreted as follows: Lower LogMAR values indicates better vision. Higher LogMAR values indicates worse vision.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 260Mean change from Baseline to Week 260 in sensitivity as measured by the full-field stimulus testing - Light Adapted in the treated eye and untreated eye. Full-field stimulus testing was performed for three stimulus colors - blue, red, and white.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 260Mean change from Baseline to Week 260 in sensitivity as measured by the full-field stimulus testing - Dark Adapted in the treated eye and untreated eye. Full-field stimulus testing was performed for three stimulus colors - blue, red, and white.
Outcome measures
Outcome data not reported
Adverse Events
ATSN-101 Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ATSN-101 Cohort 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
ATSN-101 Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ATSN-101 Cohort 4 (Adult Expansion)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ATSN-101 Cohort 5 (Pediatric Expansion)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATSN-101 Cohort 1
n=3 participants at risk
ATSN-101 single dose of 1.0x10\^10 vg/eye.
|
ATSN-101 Cohort 2
n=3 participants at risk
ATSN-101 single dose of 3.0x10\^10 vg/eye.
|
ATSN-101 Cohort 3
n=3 participants at risk
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 4 (Adult Expansion)
n=3 participants at risk
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 5 (Pediatric Expansion)
n=3 participants at risk
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
|---|---|---|---|---|---|
|
Eye disorders
Macular Hole
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Infections and infestations
Endopthalmitis
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
Other adverse events
| Measure |
ATSN-101 Cohort 1
n=3 participants at risk
ATSN-101 single dose of 1.0x10\^10 vg/eye.
|
ATSN-101 Cohort 2
n=3 participants at risk
ATSN-101 single dose of 3.0x10\^10 vg/eye.
|
ATSN-101 Cohort 3
n=3 participants at risk
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 4 (Adult Expansion)
n=3 participants at risk
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
ATSN-101 Cohort 5 (Pediatric Expansion)
n=3 participants at risk
ATSN-101 single dose of 1.0x10\^11 vg/eye.
|
|---|---|---|---|---|---|
|
Eye disorders
Conjunctival Haemorrhage
|
100.0%
3/3 • Number of events 3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
100.0%
3/3 • Number of events 3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
66.7%
2/3 • Number of events 2 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
66.7%
2/3 • Number of events 2 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
100.0%
3/3 • Number of events 3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Hypotony Of Eye
|
66.7%
2/3 • Number of events 2 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
66.7%
2/3 • Number of events 2 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
66.7%
2/3 • Number of events 2 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Ocular Discomfort
|
100.0%
3/3 • Number of events 3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
100.0%
3/3 • Number of events 3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
66.7%
2/3 • Number of events 2 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
66.7%
2/3 • Number of events 2 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
66.7%
2/3 • Number of events 2 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Retinal Tear
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Vitreal Cells
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Ocular Hypertension
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 2 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Eye Inflammation
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Eye Pain
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Vitritis
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Retinal Haemorrhage
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Retinal Degeneration
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Anterior Chamber Cell
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
0.00%
0/3 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
33.3%
1/3 • Number of events 1 • From Baseline through Week 52
AEs are classified into predefined standard categories according to chronological criteria: Treatment-emergent AEs (TEAEs): AEs that occurred or worsened during the TEAE period. An overview of all-cause mortality TEAEs, serious TEAEs, and all other AEs (not serious) for the safety population in each cohort is summarized.
|
Additional Information
Dan Yoon, MD, Sr. Director of Clinical Development
Atsena Therapeutics
Phone: 984-262-7004
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60