Trial Outcomes & Findings for Study in Subjects With Small Primary Choroidal Melanoma (NCT NCT03052127)
NCT ID: NCT03052127
Last Updated: 2024-02-01
Results Overview
Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Informed consent through 1-2 years
Results posted on
2024-02-01
Participant Flow
A total of 57 participants with Primary Choroidal Melanoma at 15 sites in the USA were enrolled and 56 were treated with at least 1 dose of AU-011 at 3 dose levels and repeat dose regimens in 1 or 2 treatment cycles with 1 or 2 laser applications.
This open-label, multicenter, dose escalation trial with expansion cohorts was designed to evaluate the safety, immunogenicity, and efficacy of up to 2 treatment cycles of intravitreal (IVT) AU-011 aimed to enroll approximately 60 participants with small primary CM. The tables were created for overall and by cohort as part of the study design. Each study participant contributed only 1 eye (study eye).
Participant milestones
| Measure |
Cohort 1 (Light-activated AU-011)
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 2 (Single Medium Dose Light-activated AU-011)
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 3 (Single High Dose Light-activated AU-011)
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 10 (Observation Until Documented Growth of Tumor)
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011 x 2 Lasers)
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
12
|
3
|
5
|
13
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
3
|
2
|
2
|
2
|
2
|
7
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
1
|
1
|
1
|
1
|
5
|
3
|
5
|
13
|
Reasons for withdrawal
| Measure |
Cohort 1 (Light-activated AU-011)
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 2 (Single Medium Dose Light-activated AU-011)
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 3 (Single High Dose Light-activated AU-011)
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 10 (Observation Until Documented Growth of Tumor)
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011 x 2 Lasers)
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Discontinuation by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
2
|
5
|
13
|
|
Overall Study
Inability to comply with trial requirements
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COVID-19 restrictions and Investigator discretion
|
1
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study in Subjects With Small Primary Choroidal Melanoma
Baseline characteristics by cohort
| Measure |
Cohort 1 (Light-activated AU-011)
n=3 Participants
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 2 (Single Medium Dose Light-activated AU-011)
n=3 Participants
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 3 (Single High Dose Light-activated AU-011)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=12 Participants
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 10 (Observation Until Documented Growth of Tumor)
n=3 Participants
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
n=5 Participants
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
n=13 Participants
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.7 Years
STANDARD_DEVIATION 6.51 • n=5 Participants
|
61.3 Years
STANDARD_DEVIATION 10.02 • n=7 Participants
|
65.3 Years
STANDARD_DEVIATION 5.13 • n=5 Participants
|
50.3 Years
STANDARD_DEVIATION 9.07 • n=4 Participants
|
52.0 Years
STANDARD_DEVIATION 11.53 • n=21 Participants
|
56.0 Years
STANDARD_DEVIATION 13.11 • n=10 Participants
|
48.0 Years
STANDARD_DEVIATION 14.93 • n=115 Participants
|
57.0 Years
STANDARD_DEVIATION 13.00 • n=24 Participants
|
57.1 Years
STANDARD_DEVIATION 10.47 • n=42 Participants
|
58.0 Years
STANDARD_DEVIATION 9.64 • n=42 Participants
|
68.8 Years
STANDARD_DEVIATION 4.66 • n=42 Participants
|
49.5 Years
STANDARD_DEVIATION 17.85 • n=42 Participants
|
55.7 Years
STANDARD_DEVIATION 12.89 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
25 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
32 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
55 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
56 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
3 participants
n=115 Participants
|
3 participants
n=24 Participants
|
12 participants
n=42 Participants
|
3 participants
n=42 Participants
|
5 participants
n=42 Participants
|
13 participants
n=42 Participants
|
57 participants
n=36 Participants
|
|
Baseline Tumor Characteristics
Tumor lesion thickness
|
1.9 millimeters
STANDARD_DEVIATION 0.58 • n=5 Participants
|
2.7 millimeters
STANDARD_DEVIATION 0.73 • n=7 Participants
|
2.4 millimeters
STANDARD_DEVIATION 0.35 • n=5 Participants
|
2.0 millimeters
STANDARD_DEVIATION 0.26 • n=4 Participants
|
2.2 millimeters
STANDARD_DEVIATION 0.23 • n=21 Participants
|
2.2 millimeters
STANDARD_DEVIATION 0.15 • n=10 Participants
|
2.2 millimeters
STANDARD_DEVIATION 0.54 • n=115 Participants
|
2.9 millimeters
STANDARD_DEVIATION 0.32 • n=24 Participants
|
2.1 millimeters
STANDARD_DEVIATION 0.42 • n=42 Participants
|
2.6 millimeters
STANDARD_DEVIATION 0.38 • n=42 Participants
|
1.9 millimeters
STANDARD_DEVIATION 0.38 • n=42 Participants
|
1.8 millimeters
STANDARD_DEVIATION 0.6 • n=42 Participants
|
2.1 millimeters
STANDARD_DEVIATION 0.52 • n=36 Participants
|
|
Baseline Tumor Characteristics
Tumor largest basal diameter
|
7.7 millimeters
STANDARD_DEVIATION 2.2 • n=5 Participants
|
8.4 millimeters
STANDARD_DEVIATION 1.4 • n=7 Participants
|
7.7 millimeters
STANDARD_DEVIATION 1.4 • n=5 Participants
|
7.8 millimeters
STANDARD_DEVIATION 1.7 • n=4 Participants
|
8.9 millimeters
STANDARD_DEVIATION 2.2 • n=21 Participants
|
7.5 millimeters
STANDARD_DEVIATION 1.2 • n=10 Participants
|
7.9 millimeters
STANDARD_DEVIATION 1.0 • n=115 Participants
|
12.3 millimeters
STANDARD_DEVIATION 1.5 • n=24 Participants
|
9.5 millimeters
STANDARD_DEVIATION 2.7 • n=42 Participants
|
9.7 millimeters
STANDARD_DEVIATION 2.1 • n=42 Participants
|
7.5 millimeters
STANDARD_DEVIATION 1.1 • n=42 Participants
|
7.9 millimeters
STANDARD_DEVIATION 1.5 • n=42 Participants
|
8.6 millimeters
STANDARD_DEVIATION 2.1 • n=36 Participants
|
|
Baseline Tumor Characteristics
Distance from fovea
|
4.8 millimeters
STANDARD_DEVIATION 0.71 • n=5 Participants
|
3.8 millimeters
STANDARD_DEVIATION 2.4 • n=7 Participants
|
4.6 millimeters
STANDARD_DEVIATION 0.95 • n=5 Participants
|
4.9 millimeters
STANDARD_DEVIATION 3.3 • n=4 Participants
|
1.8 millimeters
STANDARD_DEVIATION 2.1 • n=21 Participants
|
3.8 millimeters
STANDARD_DEVIATION 1.8 • n=10 Participants
|
5.0 millimeters
STANDARD_DEVIATION 5.0 • n=115 Participants
|
6.1 millimeters
STANDARD_DEVIATION 2.9 • n=24 Participants
|
2.9 millimeters
STANDARD_DEVIATION 2.0 • n=42 Participants
|
3.9 millimeters
STANDARD_DEVIATION 3.7 • n=42 Participants
|
3.6 millimeters
STANDARD_DEVIATION 4.4 • n=42 Participants
|
0.9 millimeters
STANDARD_DEVIATION 0.7 • n=42 Participants
|
3.2 millimeters
STANDARD_DEVIATION 2.7 • n=36 Participants
|
|
Baseline Tumor Characteristics
Distance from nerve edge
|
7.7 millimeters
STANDARD_DEVIATION 1.4 • n=5 Participants
|
2.1 millimeters
STANDARD_DEVIATION 2.7 • n=7 Participants
|
6.5 millimeters
STANDARD_DEVIATION 2.7 • n=5 Participants
|
2.2 millimeters
STANDARD_DEVIATION 3.3 • n=4 Participants
|
1.7 millimeters
STANDARD_DEVIATION 1.5 • n=21 Participants
|
6.5 millimeters
STANDARD_DEVIATION 1.4 • n=10 Participants
|
4.0 millimeters
STANDARD_DEVIATION 5.1 • n=115 Participants
|
4.5 millimeters
STANDARD_DEVIATION 7.6 • n=24 Participants
|
2.6 millimeters
STANDARD_DEVIATION 2.2 • n=42 Participants
|
3.0 millimeters
STANDARD_DEVIATION 1.8 • n=42 Participants
|
3.8 millimeters
STANDARD_DEVIATION 3.6 • n=42 Participants
|
2.9 millimeters
STANDARD_DEVIATION 1.5 • n=42 Participants
|
3.6 millimeters
STANDARD_DEVIATION 3.0 • n=36 Participants
|
|
Baseline Risk factors
Documented Growth
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
35 Participants
n=36 Participants
|
|
Baseline Risk factors
Subretinal fluid
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
54 Participants
n=36 Participants
|
|
Baseline Risk factors
Orange pigmentation
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
46 Participants
n=36 Participants
|
|
Baseline Risk factors
Vision loss
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
|
Baseline Risk factors
Flashes or floaters
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
27 Participants
n=36 Participants
|
|
Visual Acuity Scores (ETDRS Letters) in Both Eyes
Study Eye
|
89.7 letters on ETDRS scale
STANDARD_DEVIATION 0.58 • n=5 Participants
|
81.0 letters on ETDRS scale
STANDARD_DEVIATION 14.18 • n=7 Participants
|
87.3 letters on ETDRS scale
STANDARD_DEVIATION 4.93 • n=5 Participants
|
88.3 letters on ETDRS scale
STANDARD_DEVIATION 14.36 • n=4 Participants
|
75.7 letters on ETDRS scale
STANDARD_DEVIATION 10.69 • n=21 Participants
|
87.0 letters on ETDRS scale
STANDARD_DEVIATION 3.61 • n=10 Participants
|
87.3 letters on ETDRS scale
STANDARD_DEVIATION 5.13 • n=115 Participants
|
82.7 letters on ETDRS scale
STANDARD_DEVIATION 3.21 • n=24 Participants
|
82.9 letters on ETDRS scale
STANDARD_DEVIATION 10.13 • n=42 Participants
|
86.0 letters on ETDRS scale
STANDARD_DEVIATION 12.7 • n=42 Participants
|
81.2 letters on ETDRS scale
STANDARD_DEVIATION 6.34 • n=42 Participants
|
77.9 letters on ETDRS scale
STANDARD_DEVIATION 11.83 • n=42 Participants
|
82.6 letters on ETDRS scale
STANDARD_DEVIATION 9.83 • n=36 Participants
|
|
Visual Acuity Scores (ETDRS Letters) in Both Eyes
Fellow Eye
|
86.3 letters on ETDRS scale
STANDARD_DEVIATION 4.62 • n=5 Participants
|
72.7 letters on ETDRS scale
STANDARD_DEVIATION 17.62 • n=7 Participants
|
80.0 letters on ETDRS scale
STANDARD_DEVIATION 13.86 • n=5 Participants
|
91.7 letters on ETDRS scale
STANDARD_DEVIATION 4.73 • n=4 Participants
|
90.3 letters on ETDRS scale
STANDARD_DEVIATION 1.53 • n=21 Participants
|
86.0 letters on ETDRS scale
STANDARD_DEVIATION 7.21 • n=10 Participants
|
89.0 letters on ETDRS scale
STANDARD_DEVIATION 2.65 • n=115 Participants
|
75.0 letters on ETDRS scale
STANDARD_DEVIATION 19.97 • n=24 Participants
|
88.6 letters on ETDRS scale
STANDARD_DEVIATION 7.08 • n=42 Participants
|
91.0 letters on ETDRS scale
STANDARD_DEVIATION 4.58 • n=42 Participants
|
86.2 letters on ETDRS scale
STANDARD_DEVIATION 7.16 • n=42 Participants
|
85.1 letters on ETDRS scale
STANDARD_DEVIATION 9.02 • n=42 Participants
|
85.7 letters on ETDRS scale
STANDARD_DEVIATION 9.57 • n=36 Participants
|
PRIMARY outcome
Timeframe: Informed consent through 1-2 yearsPopulation: All participants who received at least 1 dose of AU-011 were used for safety analyses. Adverse events were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.
Outcome measures
| Measure |
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=12 Participants
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 10 (Observation Until Documented Growth of Tumor)
n=2 Participants
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
n=5 Participants
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
n=13 Participants
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 1 (Light-activated AU-011)
n=3 Participants
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 2 (Single Medium Dose Light-activated AU-011)
n=3 Participants
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 3 (Single High Dose Light-activated AU-011)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
12 Participants
|
2 Participants
|
5 Participants
|
13 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Screening to various time points through 24 monthsPopulation: Subjects who had at least one post-AU-011 dose result were defined in this study as being evaluable for assessment of treatment-induced antibodies to AU-011. Negative ADA refers to all negative values at baseline and post-treatment Treatment-induced ADA refers to negative value at baseline and at least 1 positive result post-treatment Treatment-unaffected ADA refers to positive value at baseline and at least 1 reported result post-treatment
Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)
Outcome measures
| Measure |
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=12 Participants
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 10 (Observation Until Documented Growth of Tumor)
n=2 Participants
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
n=5 Participants
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
n=13 Participants
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 1 (Light-activated AU-011)
n=3 Participants
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 2 (Single Medium Dose Light-activated AU-011)
n=3 Participants
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 3 (Single High Dose Light-activated AU-011)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity (Anti-AU-011 Antibody Analysis)
Negative ADA
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Immunogenicity (Anti-AU-011 Antibody Analysis)
Treatment-induced ADA
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
1 Participants
|
5 Participants
|
11 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Immunogenicity (Anti-AU-011 Antibody Analysis)
Treatment-unaffected ADA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Change from baseline following treatment and at each subsequent visit through Week 52Population: The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011. Note: The Baseline tumor thickness (TT) values reported for Cohort 10 in the table below (i.e., 2.583 (0.542)) includes only 2 participants who received AU-011. However, the TT values reported in the Baseline Characteristics table (i.e., 2.6 (0.38) includes 3 participants enrolled in the study (ITT population).
Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound.
Outcome measures
| Measure |
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=12 Participants
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 10 (Observation Until Documented Growth of Tumor)
n=3 Participants
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
n=5 Participants
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
n=13 Participants
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 1 (Light-activated AU-011)
n=3 Participants
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 2 (Single Medium Dose Light-activated AU-011)
n=3 Participants
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 3 (Single High Dose Light-activated AU-011)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Baseline
|
2.233 millimeters
Standard Deviation 0.233
|
2.233 millimeters
Standard Deviation 0.153
|
2.167 millimeters
Standard Deviation 0.536
|
2.889 millimeters
Standard Deviation 0.320
|
2.072 millimeters
Standard Deviation 0.417
|
2.583 millimeters
Standard Deviation 0.542
|
1.920 millimeters
Standard Deviation 0.384
|
1.826 millimeters
Standard Deviation 0.604
|
1.872 millimeters
Standard Deviation 0.576
|
2.678 millimeters
Standard Deviation 0.734
|
2.389 millimeters
Standard Deviation 0.347
|
2.033 millimeters
Standard Deviation 0.265
|
|
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Day 29 (Visit 8)
|
0.011 millimeters
Standard Deviation 0.126
|
0.033 millimeters
Standard Deviation 0.120
|
0.078 millimeters
Standard Deviation 0.164
|
0.111 millimeters
Standard Deviation 0.138
|
-0.022 millimeters
Standard Deviation 0.109
|
0 millimeters
Standard Deviation 0.047
|
0.017 millimeters
Standard Deviation 0.104
|
0.018 millimeters
Standard Deviation 0.069
|
-0.061 millimeters
Standard Deviation 0.151
|
0.056 millimeters
Standard Deviation 0.158
|
0.067 millimeters
Standard Deviation 0.240
|
-0.044 millimeters
Standard Deviation 0.184
|
|
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Week 8 (Visit 10)
|
0.078 millimeters
Standard Deviation 0.039
|
0.056 millimeters
Standard Deviation 0.126
|
0.21 millimeters
Standard Deviation 0.184
|
0.122 millimeters
Standard Deviation 0.126
|
-0.012 millimeters
Standard Deviation 0.111
|
0.150 millimeters
Standard Deviation 0.071
|
0.020 millimeters
Standard Deviation 0.119
|
-0.010 millimeters
Standard Deviation 0.080
|
-0.006 millimeters
Standard Deviation 0.177
|
0.267 millimeters
Standard Deviation 0.200
|
0.111 millimeters
Standard Deviation 0.337
|
-0.111 millimeters
Standard Deviation 0.204
|
|
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Week 12 (Visit 11)
|
0.022 millimeters
Standard Deviation 0.077
|
-0.100 millimeters
Standard Deviation 0.120
|
0.333 millimeters
Standard Deviation 0.208
|
0.233 millimeters
Standard Deviation 0.219
|
0.028 millimeters
Standard Deviation 0.175
|
—
|
0.027 millimeters
Standard Deviation 0.130
|
-0.049 millimeters
Standard Deviation 0.141
|
0.033 millimeters
Standard Deviation 0.233
|
0.333 millimeters
Standard Deviation 0.285
|
0.144 millimeters
Standard Deviation 0.252
|
-0.156 millimeters
Standard Deviation 0.269
|
|
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Week 26 (Visit 12)
|
0.211 millimeters
Standard Deviation 0.278
|
0.078 millimeters
Standard Deviation 0.250
|
0.733 millimeters
Standard Deviation 0.569
|
0.667 millimeters
Standard Deviation 0.839
|
0.092 millimeters
Standard Deviation 0.25
|
1.20 millimeters
Standard Deviation 1.273
|
0.087 millimeters
Standard Deviation 0.112
|
-0.117 millimeters
Standard Deviation 0.400
|
-0.117 millimeters
Standard Deviation 0.118
|
1.067 millimeters
Standard Deviation 1.393
|
0.267 millimeters
Standard Deviation 0.635
|
-0.044 millimeters
Standard Deviation 0.154
|
|
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Week 39 (Visit 13)
|
0.322 millimeters
Standard Deviation 0.320
|
0.044 millimeters
Standard Deviation 0.217
|
0.133 millimeters
|
0.300 millimeters
Standard Deviation 0.141
|
0.164 millimeters
Standard Deviation 0.194
|
2.350 millimeters
Standard Deviation 2.616
|
0.147 millimeters
Standard Deviation 0.216
|
-0.039 millimeters
Standard Deviation 0.401
|
-0.067 millimeters
Standard Deviation 0.047
|
0.978 millimeters
Standard Deviation 0.956
|
-0.067 millimeters
Standard Deviation 0.094
|
-0.333 millimeters
Standard Deviation 0.384
|
|
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Day 2 (Visit 3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.56 millimeters
Standard Deviation 0.069
|
0 millimeters
Standard Deviation 0.100
|
-0.011 millimeters
Standard Deviation 0.038
|
-0.033 millimeters
Standard Deviation 0
|
|
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Day 8 (Visit 4)
|
-0.011 millimeters
Standard Deviation 0.039
|
-0.050 millimeters
Standard Deviation 0.071
|
0.067 millimeters
Standard Deviation 0.033
|
-0.044 millimeters
Standard Deviation 0.077
|
-0.019 millimeters
Standard Deviation 0.73
|
0.017 millimeters
Standard Deviation 0.024
|
0.013 millimeters
Standard Deviation 0.051
|
0.018 millimeters
Standard Deviation 0.059
|
-0.042 millimeters
Standard Deviation 0.012
|
0.022 millimeters
Standard Deviation 0.084
|
0.044 millimeters
Standard Deviation 0.084
|
0.044 millimeters
Standard Deviation 0.039
|
|
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Day 15 (Visit 6)
|
0.033 millimeters
Standard Deviation 0.067
|
0 millimeters
Standard Deviation 0.047
|
0.044 millimeters
Standard Deviation 0.084
|
0.078 millimeters
Standard Deviation 0.051
|
-0.028 millimeters
Standard Deviation 0.107
|
0.017 millimeters
Standard Deviation 0.165
|
0.007 millimeters
Standard Deviation 0.159
|
0.021 millimeters
Standard Deviation 0.062
|
-0.017 millimeters
Standard Deviation 0.024
|
0.044 millimeters
Standard Deviation 0.135
|
0.033 millimeters
Standard Deviation 0.133
|
0.044 millimeters
Standard Deviation 0.019
|
|
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Week 52 (Visit 14)
|
0.500 millimeters
Standard Deviation 0.404
|
0.156 millimeters
Standard Deviation 0.356
|
0.433 millimeters
Standard Deviation 0.404
|
0.456 millimeters
Standard Deviation 0.320
|
0.222 millimeters
Standard Deviation 0.254
|
2.750 millimeters
Standard Deviation 2.993
|
0.247 millimeters
Standard Deviation 0.315
|
0.128 millimeters
Standard Deviation 0.683
|
-0.067 millimeters
Standard Deviation 0.094
|
0.189 millimeters
Standard Deviation 1.151
|
-0.067 millimeters
Standard Deviation 0.047
|
-0.300 millimeters
Standard Deviation 0.449
|
SECONDARY outcome
Timeframe: Change from baseline following treatment and at each subsequent visit through Week 52Population: The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011. Note: The Baseline tumor Largest Basal Diameter (LBD) values reported for Cohort 10 in the table below (i.e., 10.088 (2.825)) includes only 2 participants who received AU-011. However, the LBD values reported in the Baseline Characteristics table (i.e., 9.7 (2.1) includes 3 participants enrolled in Cohort 10 (ITT population).
Change from Baseline in tumor Largest Basal Diameter (LBD) assessed at each study visit based on fundus photos (millimeters) in participants treated with AU-011.
Outcome measures
| Measure |
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=12 Participants
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 10 (Observation Until Documented Growth of Tumor)
n=3 Participants
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
n=5 Participants
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
n=13 Participants
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 1 (Light-activated AU-011)
n=3 Participants
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 2 (Single Medium Dose Light-activated AU-011)
n=3 Participants
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 3 (Single High Dose Light-activated AU-011)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Day 2 (Visit 3)
|
-0.308 millimeters
Standard Deviation 0.103
|
0.063 millimeters
Standard Deviation 0.201
|
0.083 millimeters
Standard Deviation 0.131
|
0.410 millimeters
|
-0.161 millimeters
Standard Deviation 0.496
|
0.285 millimeters
|
-0.021 millimeters
Standard Deviation 0.086
|
-0.012 millimeters
Standard Deviation 0.234
|
0.203 millimeters
Standard Deviation 0.414
|
0.280 millimeters
Standard Deviation 0.156
|
0.023 millimeters
Standard Deviation 0.253
|
0.092 millimeters
Standard Deviation 0.226
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Day 9 (Visit 5)
|
-0.007 millimeters
Standard Deviation 0.363
|
—
|
0.265 millimeters
Standard Deviation 0.141
|
0.918 millimeters
Standard Deviation 0.378
|
-0.175 millimeters
Standard Deviation 0.482
|
-0.010 millimeters
Standard Deviation 0.481
|
0.060 millimeters
Standard Deviation 0.048
|
0.066 millimeters
Standard Deviation 0.197
|
—
|
—
|
—
|
0.473 millimeters
Standard Deviation 0.464
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Day 15 (Visit 6)
|
0.087 millimeters
Standard Deviation 0.253
|
0.500 millimeters
Standard Deviation 0.120
|
0.285 millimeters
Standard Deviation 0.069
|
0.730 millimeters
Standard Deviation 0.644
|
-0.130 millimeters
Standard Deviation 0.579
|
0.250 millimeters
|
-0.073 millimeters
Standard Deviation 0.129
|
0.175 millimeters
Standard Deviation 0.319
|
0.060 millimeters
Standard Deviation 0.007
|
0.147 millimeters
Standard Deviation 0.140
|
0.417 millimeters
Standard Deviation 0.212
|
0.225 millimeters
Standard Deviation 0.065
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Day 16 (Visit 7)
|
-0.010 millimeters
Standard Deviation 0.426
|
—
|
0.317 millimeters
Standard Deviation 0.025
|
1.120 millimeters
Standard Deviation 1.004
|
-0.049 millimeters
Standard Deviation 0.899
|
0.245 millimeters
|
0.037 millimeters
Standard Deviation 0.928
|
0.265 millimeters
Standard Deviation 0.342
|
—
|
—
|
—
|
—
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Week 6 (Visit 9)
|
0.072 millimeters
Standard Deviation 0.362
|
0.285 millimeters
Standard Deviation 0.021
|
0.333 millimeters
Standard Deviation 0.032
|
0.895 millimeters
|
0.626 millimeters
Standard Deviation 0.918
|
—
|
-0.222 millimeters
Standard Deviation 0.251
|
0.293 millimeters
Standard Deviation 0.369
|
—
|
—
|
0.730 millimeters
Standard Deviation 0.265
|
0.627 millimeters
Standard Deviation 0.477
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Week 8 (Visit 10)
|
0.168 millimeters
Standard Deviation 0.339
|
0.122 millimeters
Standard Deviation 0.214
|
0.970 millimeters
Standard Deviation 0.599
|
2.56 millimeters
|
0.981 millimeters
Standard Deviation 1.641
|
-0.395 millimeters
|
0.033 millimeters
Standard Deviation 0.287
|
0.314 millimeters
Standard Deviation 0.406
|
-0.472 millimeters
Standard Deviation 0.774
|
0.273 millimeters
Standard Deviation 0.475
|
0.288 millimeters
Standard Deviation 0.239
|
0.807 millimeters
Standard Deviation 0.478
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Week 12 (Visit 11)
|
0.103 millimeters
Standard Deviation 0.450
|
0.497 millimeters
Standard Deviation 0.138
|
0.930 millimeters
Standard Deviation 0.552
|
1.013 millimeters
Standard Deviation 0.067
|
0.534 millimeters
Standard Deviation 1.173
|
-0.115 millimeters
Standard Deviation 0.064
|
0.503 millimeters
Standard Deviation 0.236
|
0.657 millimeters
Standard Deviation 0.703
|
-0.468 millimeters
Standard Deviation 0.842
|
0.347 millimeters
Standard Deviation 0.289
|
0.657 millimeters
Standard Deviation 0.144
|
0.963 millimeters
Standard Deviation 0.752
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Week 39 (Visit 13)
|
0.445 millimeters
Standard Deviation 0.507
|
0.730 millimeters
Standard Deviation 0.692
|
2.552 millimeters
Standard Deviation 1.552
|
2.635 millimeters
|
1.342 millimeters
Standard Deviation 1.200
|
0.065 millimeters
Standard Deviation 0.481
|
0.977 millimeters
Standard Deviation 0.365
|
1.224 millimeters
Standard Deviation 0.952
|
0.070 millimeters
Standard Deviation 0.332
|
0.805 millimeters
Standard Deviation 0.781
|
0.545 millimeters
Standard Deviation 0.332
|
0.740 millimeters
Standard Deviation 0.014
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Week 52 (Visit 14)
|
0.853 millimeters
Standard Deviation 1.199
|
0.937 millimeters
Standard Deviation 0.814
|
2.993 millimeters
Standard Deviation 1.095
|
1.853 millimeters
Standard Deviation 0.661
|
1.774 millimeters
Standard Deviation 1.254
|
1.630 millimeters
|
1.197 millimeters
Standard Deviation 0.919
|
1.457 millimeters
Standard Deviation 1.456
|
0.230 millimeters
Standard Deviation 0.453
|
0.827 millimeters
Standard Deviation 0.725
|
0.427 millimeters
Standard Deviation 0.180
|
1.605 millimeters
Standard Deviation 1.286
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Baseline
|
8.853 millimeters
Standard Deviation 2.146
|
7.492 millimeters
Standard Deviation 1.227
|
7.927 millimeters
Standard Deviation 1.030
|
12.257 millimeters
Standard Deviation 1.533
|
9.533 millimeters
Standard Deviation 2.688
|
10.088 millimeters
Standard Deviation 2.825
|
7.502 millimeters
Standard Deviation 1.058
|
7.869 millimeters
Standard Deviation 1.532
|
7.740 millimeters
Standard Deviation 2.197
|
8.350 millimeters
Standard Deviation 1.400
|
7.700 millimeters
Standard Deviation 1.375
|
7.815 millimeters
Standard Deviation 1.681
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Day 8 (Visit 4)
|
0.015 millimeters
Standard Deviation 0.566
|
0.080 millimeters
Standard Deviation 0.339
|
0.105 millimeters
Standard Deviation 0.102
|
0.340 millimeters
Standard Deviation 0.149
|
-0.154 millimeters
Standard Deviation 0.552
|
0.67 millimeters
Standard Deviation 0.414
|
0.083 millimeters
Standard Deviation 0.215
|
0.168 millimeters
Standard Deviation 0.329
|
0.070 millimeters
Standard Deviation 0.198
|
-0.035 millimeters
Standard Deviation 0.347
|
0.225 millimeters
Standard Deviation 0.628
|
0.383 millimeters
Standard Deviation 0.160
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Day 29 (Visit 8)
|
0.198 millimeters
Standard Deviation 0.610
|
0.115 millimeters
Standard Deviation 0.050
|
0.343 millimeters
Standard Deviation 0.060
|
1.660 millimeters
|
0.019 millimeters
Standard Deviation 0.498
|
—
|
0.223 millimeters
Standard Deviation 0.335
|
0.199 millimeters
Standard Deviation 0.549
|
-0.165 millimeters
Standard Deviation 0.184
|
0.003 millimeters
Standard Deviation 0.339
|
0.625 millimeters
Standard Deviation 0.435
|
0.580 millimeters
Standard Deviation 0.180
|
|
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Week 26 (Visit 12)
|
0.412 millimeters
Standard Deviation 1.086
|
0.695 millimeters
Standard Deviation 0.785
|
2.70 millimeters
Standard Deviation 0.961
|
2.857 millimeters
Standard Deviation 1.425
|
1.381 millimeters
Standard Deviation 1.223
|
0.490 millimeters
Standard Deviation 0.212
|
0.738 millimeters
Standard Deviation 0.499
|
0.666 millimeters
Standard Deviation 0.803
|
0.085 millimeters
Standard Deviation 0.212
|
-0.032 millimeters
Standard Deviation 0.618
|
0.413 millimeters
Standard Deviation 0.350
|
0.998 millimeters
Standard Deviation 0.959
|
SECONDARY outcome
Timeframe: Change from baseline following treatment and at each subsequent visit through Week 52Population: The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011.
Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit.
Outcome measures
| Measure |
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=3 Participants
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=12 Participants
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 10 (Observation Until Documented Growth of Tumor)
n=3 Participants
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
n=5 Participants
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
n=13 Participants
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 1 (Light-activated AU-011)
n=3 Participants
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 2 (Single Medium Dose Light-activated AU-011)
n=3 Participants
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 3 (Single High Dose Light-activated AU-011)
n=3 Participants
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
n=3 Participants
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Baseline
|
75.7 ETDRS letters
Standard Deviation 10.69
|
87.0 ETDRS letters
Standard Deviation 3.61
|
87.3 ETDRS letters
Standard Deviation 5.13
|
82.7 ETDRS letters
Standard Deviation 3.21
|
82.9 ETDRS letters
Standard Deviation 10.13
|
86.0 ETDRS letters
Standard Deviation 12.77
|
81.2 ETDRS letters
Standard Deviation 6.34
|
77.9 ETDRS letters
Standard Deviation 11.83
|
89.7 ETDRS letters
Standard Deviation 0.58
|
81.0 ETDRS letters
Standard Deviation 14.18
|
87.3 ETDRS letters
Standard Deviation 4.93
|
88.3 ETDRS letters
Standard Deviation 14.36
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Day 2 (Visit 3)
|
-1.0 ETDRS letters
Standard Deviation 1.41
|
-11.0 ETDRS letters
Standard Deviation 6.56
|
2.0 ETDRS letters
Standard Deviation 2.00
|
-15.0 ETDRS letters
Standard Deviation 16.52
|
-4.1 ETDRS letters
Standard Deviation 9.49
|
-14.0 ETDRS letters
Standard Deviation 5.66
|
-10.2 ETDRS letters
Standard Deviation 16.63
|
-0.5 ETDRS letters
Standard Deviation 4.67
|
-5.3 ETDRS letters
Standard Deviation 4.04
|
-4.0 ETDRS letters
Standard Deviation 12.17
|
-14.3 ETDRS letters
Standard Deviation 17.04
|
-4.7 ETDRS letters
Standard Deviation 9.07
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Day 8 (Visit 4)
|
-4.3 ETDRS letters
Standard Deviation 4.62
|
-6.3 ETDRS letters
Standard Deviation 8.39
|
3.3 ETDRS letters
Standard Deviation 2.52
|
-13.0 ETDRS letters
Standard Deviation 23.4
|
0.1 ETDRS letters
Standard Deviation 3.32
|
0.5 ETDRS letters
Standard Deviation 3.54
|
0.4 ETDRS letters
Standard Deviation 3.36
|
1.6 ETDRS letters
Standard Deviation 4.29
|
-2.3 ETDRS letters
Standard Deviation 2.52
|
5.3 ETDRS letters
Standard Deviation 3.21
|
-3.3 ETDRS letters
Standard Deviation 4.93
|
-1.3 ETDRS letters
Standard Deviation 2.08
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Week 6 (Visit 9)
|
-10.0 ETDRS letters
Standard Deviation 7.55
|
-9.0 ETDRS letters
Standard Deviation 15.52
|
-5.3 ETDRS letters
Standard Deviation 9.5
|
-10.0 ETDRS letters
Standard Deviation 10.15
|
-8.7 ETDRS letters
Standard Deviation 7.40
|
-13.5 ETDRS letters
Standard Deviation 17.68
|
-18.6 ETDRS letters
Standard Deviation 23.39
|
-7.5 ETDRS letters
Standard Deviation 16.10
|
-26.0 ETDRS letters
|
—
|
-2.3 ETDRS letters
Standard Deviation 4.51
|
-9.0 ETDRS letters
Standard Deviation 7.55
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Week 52 (Visit 14)
|
-7.7 ETDRS letters
Standard Deviation 22.01
|
-10.7 ETDRS letters
Standard Deviation 22.85
|
-8.3 ETDRS letters
Standard Deviation 13.65
|
-1.0 ETDRS letters
Standard Deviation 6.08
|
-15.7 ETDRS letters
Standard Deviation 26.56
|
-25.0 ETDRS letters
Standard Deviation 11.31
|
-17.2 ETDRS letters
Standard Deviation 20.91
|
-16.1 ETDRS letters
Standard Deviation 18.34
|
-3.0 ETDRS letters
Standard Deviation 2.83
|
-18.7 ETDRS letters
Standard Deviation 34.93
|
1.5 ETDRS letters
Standard Deviation 2.12
|
-11.3 ETDRS letters
Standard Deviation 4.73
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Day 9 (Visit 5)
|
-9.0 ETDRS letters
Standard Deviation 2.83
|
—
|
0.3 ETDRS letters
Standard Deviation 4.16
|
-30.0 ETDRS letters
Standard Deviation 47.76
|
-3.4 ETDRS letters
Standard Deviation 8.16
|
-0.5 ETDRS letters
Standard Deviation 4.95
|
-8.2 ETDRS letters
Standard Deviation 12.50
|
-6.2 ETDRS letters
Standard Deviation 13.01
|
—
|
—
|
—
|
-3.0 ETDRS letters
Standard Deviation 6.56
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Day 15 (Visit 6)
|
-13.0 ETDRS letters
Standard Deviation 7.00
|
-13.3 ETDRS letters
Standard Deviation 17.95
|
0 ETDRS letters
Standard Deviation 8.00
|
-4.7 ETDRS letters
Standard Deviation 8.96
|
-4.0 ETDRS letters
Standard Deviation 6.97
|
3.5 ETDRS letters
Standard Deviation 2.12
|
-20.6 ETDRS letters
Standard Deviation 31.71
|
-7.1 ETDRS letters
Standard Deviation 16.32
|
-2.0 ETDRS letters
Standard Deviation 2.65
|
4.0 ETDRS letters
Standard Deviation 3.61
|
-7.0 ETDRS letters
Standard Deviation 8.19
|
-6.0 ETDRS letters
Standard Deviation 7.94
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Day 16 (Visit 7)
|
-15.7 ETDRS letters
Standard Deviation 10.26
|
—
|
-1.3 ETDRS letters
Standard Deviation 11.68
|
-17.3 ETDRS letters
Standard Deviation 12.06
|
-17.0 ETDRS letters
Standard Deviation 16.15
|
0 ETDRS letters
Standard Deviation 2.83
|
-28.0 ETDRS letters
Standard Deviation 28.02
|
-8.8 ETDRS letters
Standard Deviation 15.24
|
—
|
—
|
—
|
—
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Day 29 (Visit 8)
|
-9.3 ETDRS letters
Standard Deviation 1.15
|
-11.0 ETDRS letters
Standard Deviation 12.12
|
-13.7 ETDRS letters
Standard Deviation 23.46
|
-10.0 ETDRS letters
Standard Deviation 9.54
|
-26.0 ETDRS letters
Standard Deviation 29.60
|
-27.5 ETDRS letters
Standard Deviation 7.78
|
-26.0 ETDRS letters
Standard Deviation 25.81
|
-12.0 ETDRS letters
Standard Deviation 16.38
|
-4.3 ETDRS letters
Standard Deviation 5.86
|
-0.3 ETDRS letters
Standard Deviation 4.73
|
-9.7 ETDRS letters
Standard Deviation 8.33
|
-13.7 ETDRS letters
Standard Deviation 7.23
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Week 8 (Visit 10)
|
-14.7 ETDRS letters
Standard Deviation 14.57
|
-11.7 ETDRS letters
Standard Deviation 21.36
|
-2.0 ETDRS letters
Standard Deviation 2.65
|
-5.3 ETDRS letters
Standard Deviation 2.08
|
-6.6 ETDRS letters
Standard Deviation 8.2
|
-4.0 ETDRS letters
Standard Deviation 7.07
|
-14.2 ETDRS letters
Standard Deviation 23.12
|
-8.7 ETDRS letters
Standard Deviation 16.18
|
-6.3 ETDRS letters
Standard Deviation 2.08
|
0.3 ETDRS letters
Standard Deviation 3.79
|
-7.3 ETDRS letters
Standard Deviation 6.03
|
-5.3 ETDRS letters
Standard Deviation 4.93
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Week 12 (Visit 11)
|
-12.0 ETDRS letters
Standard Deviation 13.23
|
-11.0 ETDRS letters
Standard Deviation 21.63
|
-1.3 ETDRS letters
Standard Deviation 4.04
|
-0.7 ETDRS letters
Standard Deviation 3.06
|
-3.8 ETDRS letters
Standard Deviation 4.39
|
0 ETDRS letters
Standard Deviation 3.0
|
-14.2 ETDRS letters
Standard Deviation 21.32
|
-9.4 ETDRS letters
Standard Deviation 15.17
|
-2.3 ETDRS letters
Standard Deviation 3.79
|
4.0 ETDRS letters
Standard Deviation 1.00
|
-3.0 ETDRS letters
Standard Deviation 3.00
|
-4.0 ETDRS letters
Standard Deviation 1.73
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Week 26 (Visit 12)
|
-1.7 ETDRS letters
Standard Deviation 16.01
|
-11.3 ETDRS letters
Standard Deviation 21.39
|
-2.0 ETDRS letters
Standard Deviation 6.56
|
-0.7 ETDRS letters
Standard Deviation 4.51
|
-1.5 ETDRS letters
Standard Deviation 4.36
|
0 ETDRS letters
Standard Deviation 4.24
|
-13.0 ETDRS letters
Standard Deviation 18.64
|
-9.8 ETDRS letters
Standard Deviation 13.57
|
0.3 ETDRS letters
Standard Deviation 3.06
|
0.3 ETDRS letters
Standard Deviation 2.08
|
-3.0 ETDRS letters
Standard Deviation 2.65
|
-2.7 ETDRS letters
Standard Deviation 1.53
|
|
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Week 39 (Visit 13)
|
-7.0 ETDRS letters
Standard Deviation 23.07
|
-9.7 ETDRS letters
Standard Deviation 20.31
|
-36.0 ETDRS letters
Standard Deviation 38.18
|
-1.0 ETDRS letters
Standard Deviation 0.0
|
-8.7 ETDRS letters
Standard Deviation 25.43
|
-6.5 ETDRS letters
Standard Deviation 12.02
|
-16.8 ETDRS letters
Standard Deviation 19.27
|
-10.6 ETDRS letters
Standard Deviation 15.14
|
-4.0 ETDRS letters
Standard Deviation 5.66
|
-11.0 ETDRS letters
Standard Deviation 20.78
|
0.5 ETDRS letters
Standard Deviation 0.71
|
-11.7 ETDRS letters
Standard Deviation 4.73
|
Adverse Events
Cohort 1 (Light-activated AU-011)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 (Single Medium Dose Light-activated AU-011)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 (Single High Dose Light-activated AU-011)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 10 (Observation Until Documented Growth of Tumor)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Light-activated AU-011)
n=3 participants at risk
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 2 (Single Medium Dose Light-activated AU-011)
n=3 participants at risk
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 3 (Single High Dose Light-activated AU-011)
n=3 participants at risk
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
n=3 participants at risk
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
n=3 participants at risk
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
n=3 participants at risk
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
n=3 participants at risk
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=3 participants at risk
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=12 participants at risk
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 10 (Observation Until Documented Growth of Tumor)
n=2 participants at risk
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
n=5 participants at risk
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
n=13 participants at risk
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
Other adverse events
| Measure |
Cohort 1 (Light-activated AU-011)
n=3 participants at risk
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 2 (Single Medium Dose Light-activated AU-011)
n=3 participants at risk
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 3 (Single High Dose Light-activated AU-011)
n=3 participants at risk
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
n=3 participants at risk
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
n=3 participants at risk
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
n=3 participants at risk
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
n=3 participants at risk
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=3 participants at risk
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
n=12 participants at risk
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 10 (Observation Until Documented Growth of Tumor)
n=2 participants at risk
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
n=5 participants at risk
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
n=13 participants at risk
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Anterior chamber cell
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
25.0%
3/12 • Number of events 5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
50.0%
1/2 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
40.0%
2/5 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Anterior chamber inflammation
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
3/3 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
3/3 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
8/12 • Number of events 20 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
80.0%
4/5 • Number of events 19 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
69.2%
9/13 • Number of events 19 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Conjuctival hemorrhage
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
3/3 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 6 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
50.0%
6/12 • Number of events 11 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
2/2 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
5/5 • Number of events 13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
13/13 • Number of events 26 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Conjuctival hyperemia
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
25.0%
3/12 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
50.0%
1/2 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
80.0%
4/5 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Corneal edema
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
25.0%
3/12 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
40.0%
2/5 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Corneal disorder
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Eye pain
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
8.3%
1/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
2/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
60.0%
3/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
38.5%
5/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Keratic precipitates
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
4/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
16.7%
2/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
16.7%
2/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
8.3%
1/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
16.7%
2/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
2/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
60.0%
3/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
38.5%
5/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
58.3%
7/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
50.0%
1/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
80.0%
4/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
61.5%
8/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Retinal tear
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
8.3%
1/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Visual acuity reduced
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
4/12 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
50.0%
1/2 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
40.0%
2/5 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
53.8%
7/13 • Number of events 11 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Vitreal cells
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Vitreous detachment
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
16.7%
2/12 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
50.0%
1/2 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
30.8%
4/13 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Vitreous floaters
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
16.7%
2/12 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Vitreous haze
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 8 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
4/12 • Number of events 6 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
60.0%
3/5 • Number of events 5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
30.8%
4/13 • Number of events 7 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Vitreous opacities
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Vitritis
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
3/3 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
3/3 • Number of events 6 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
83.3%
10/12 • Number of events 16 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
50.0%
1/2 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
60.0%
3/5 • Number of events 11 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
69.2%
9/13 • Number of events 18 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Cataract
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
8.3%
1/12 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
40.0%
2/5 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
38.5%
5/13 • Number of events 7 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
60.0%
3/5 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
8.3%
1/12 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Eyelid edema
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
8.3%
1/12 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Iris adhesions
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
8.3%
1/12 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
40.0%
2/5 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
25.0%
3/12 • Number of events 5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
40.0%
2/5 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Retinal depigmentation
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
8.3%
1/12 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
8.3%
1/12 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
50.0%
1/2 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/5 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
16.7%
2/12 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
40.0%
2/5 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
General disorders
Fatigue
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
25.0%
3/12 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/13 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
16.7%
2/12 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
50.0%
1/2 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Investigations
Intraocular pressured increased
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 4 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
16.7%
2/12 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
50.0%
1/2 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
100.0%
5/5 • Number of events 9 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
61.5%
8/13 • Number of events 21 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
33.3%
1/3 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
16.7%
2/12 • Number of events 7 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
60.0%
3/5 • Number of events 7 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
7.7%
1/13 • Number of events 3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
66.7%
2/3 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/3 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/12 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
0.00%
0/2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
20.0%
1/5 • Number of events 1 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
15.4%
2/13 • Number of events 2 • 12 to 24 months
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011. Adverse events (AEs) were defined as events that were new or worsened during the treatment period. AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).
|
Additional Information
Uma Chandrasekaran, Director, Clinical Development Scientist
Aura Biosciences
Phone: 706-294-3454
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee CSA states sites may publish or publicly disclose the results of the study after disclosure is given to the Sponsor for review at least 60 days prior to the date of submission for publication. Site agrees to discuss with Sponsor with respect to the presentation of study data and timing of the disclosure.
- Publication restrictions are in place
Restriction type: OTHER