Trial Outcomes & Findings for Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema (NCT NCT02348918)
NCT ID: NCT02348918
Last Updated: 2018-12-07
Results Overview
Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
218 participants
Primary outcome timeframe
Value of 24 Weeks minus baseline value
Results posted on
2018-12-07
Participant Flow
Participant milestones
| Measure |
Luminate 1.0mg Group
Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 1.0mg
|
Luminate 2.0mg Group
Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 2.0mg
|
Luminate 3.0mg Group
Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 3.0mg
|
Avastin® Group
Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.
Avastin
|
Avastin Then Luminate 1.0 mg IVT + Sham Injection
Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Luminate 1.0mg
Avastin
|
Avastin Then Luminate 0.5 mg IVT + Sham Injection
Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Avastin
Luminate 0.5mg
|
Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Luminate 1.0mg
Avastin
|
Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT
Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Avastin
Luminate 0.5mg
|
Avastin 1.25 mg + Sham IVT
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN
Luminate 0.5mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
33
|
42
|
24
|
19
|
17
|
13
|
16
|
15
|
|
Overall Study
COMPLETED
|
39
|
33
|
42
|
24
|
19
|
17
|
13
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Luminate 1.0mg Group
n=39 Participants
Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 1.0mg
|
Luminate 2.0mg Group
n=33 Participants
Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 2.0mg
|
Luminate 3.0mg Group
n=42 Participants
Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 3.0mg
|
Avastin® Group
n=24 Participants
Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.
Avastin
|
Avastin Then Luminate 1.0 mg IVT + Sham Injection
n=19 Participants
Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Luminate 1.0mg
Avastin
|
Avastin Then Luminate 0.5 mg IVT + Sham Injection
n=17 Participants
Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Avastin
Luminate 0.5mg
|
Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT
n=13 Participants
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Luminate 1.0mg
Avastin
|
Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT
n=16 Participants
Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Avastin
Luminate 0.5mg
|
Avastin 1.25 mg + Sham IVT
n=15 Participants
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN
Luminate 0.5mg
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
135 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
83 Participants
n=42 Participants
|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
61 years
STANDARD_DEVIATION 9.91 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 8.83 • n=4 Participants
|
67.1 years
STANDARD_DEVIATION 10.47 • n=21 Participants
|
65.5 years
STANDARD_DEVIATION 9.41 • n=10 Participants
|
60.1 years
STANDARD_DEVIATION 10.92 • n=115 Participants
|
60.5 years
STANDARD_DEVIATION 8.29 • n=24 Participants
|
62.1 years
STANDARD_DEVIATION 9.35 • n=42 Participants
|
62.3 years
STANDARD_DEVIATION 9.35 • n=42 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
106 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
112 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
white
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
13 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
181 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
16 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
218 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Value of 24 Weeks minus baseline valuePrimary efficacy outcome is BCVA changes at Week 24 as compared to baseline
Outcome measures
| Measure |
Luminate 1.0mg Group
n=39 Participants
Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 1.0mg
|
Luminate 2.0mg Group
n=33 Participants
Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 2.0mg
|
Luminate 3.0mg Group
n=42 Participants
Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 3.0mg
|
Avastin® Group
n=24 Participants
Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.
Avastin
|
Avastin Then Luminate 1.0 mg IVT + Sham Injection
n=19 Participants
Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Luminate 1.0mg
Avastin
|
Avastin Then Luminate 0.5 mg IVT + Sham Injection
n=17 Participants
Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Avastin
Luminate 0.5mg
|
Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT
n=13 Participants
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Luminate 1.0mg
Avastin
|
Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT
n=16 Participants
Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Avastin
Luminate 0.5mg
|
Avastin 1.25 mg + Sham IVT
n=15 Participants
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN
Luminate 0.5mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in BCVA at Week 24
|
5.2 Letters on ETDRS eye chart
Standard Error 3
|
2.7 Letters on ETDRS eye chart
Standard Error 3
|
-1.5 Letters on ETDRS eye chart
Standard Error 3
|
7 Letters on ETDRS eye chart
Standard Error 3
|
7.1 Letters on ETDRS eye chart
Standard Error 3
|
4.6 Letters on ETDRS eye chart
Standard Error 3
|
1.4 Letters on ETDRS eye chart
Standard Error 3
|
3.9 Letters on ETDRS eye chart
Standard Error 3
|
6.7 Letters on ETDRS eye chart
Standard Error 3
|
Adverse Events
Luminate 1.0mg Group
Serious events: 8 serious events
Other events: 28 other events
Deaths: 1 deaths
Luminate 2.0mg Group
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Luminate 3.0mg Group
Serious events: 6 serious events
Other events: 25 other events
Deaths: 1 deaths
Avastin® Group
Serious events: 3 serious events
Other events: 16 other events
Deaths: 1 deaths
Avastin Then Luminate 1.0 mg IVT + Sham Injection
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Avastin Then Luminate 0.5 mg IVT + Sham Injection
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Avastin 1.25 mg + Sham IVT
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Luminate 1.0mg Group
n=39 participants at risk
Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 1.0mg
|
Luminate 2.0mg Group
n=33 participants at risk
Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 2.0mg
|
Luminate 3.0mg Group
n=42 participants at risk
Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 3.0mg
|
Avastin® Group
n=24 participants at risk
Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.
Avastin
|
Avastin Then Luminate 1.0 mg IVT + Sham Injection
n=19 participants at risk
Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Luminate 1.0mg
Avastin
|
Avastin Then Luminate 0.5 mg IVT + Sham Injection
n=17 participants at risk
Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Avastin
Luminate 0.5mg
|
Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT
n=13 participants at risk
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Luminate 1.0mg
Avastin
|
Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT
n=16 participants at risk
Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Avastin
Luminate 0.5mg
|
Avastin 1.25 mg + Sham IVT
n=15 participants at risk
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN
Luminate 0.5mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Infections and infestations
|
5.1%
2/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
3.0%
1/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
2.4%
1/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
4.2%
1/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
5.9%
1/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
13.3%
2/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Cardiac disorders
Cardiac disorders
|
5.1%
2/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
2.4%
1/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
10.5%
2/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.2%
1/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Eye disorders
eye disorders
|
7.7%
3/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
3.0%
1/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
7.1%
3/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
4.2%
1/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Metabolism and nutrition disorders
Metabolism and nutritional disorders
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
4.8%
2/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.7%
1/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
2.4%
1/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign malignant and unspecified
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
3.0%
1/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
13.3%
2/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Nervous system disorders
Nervous system disorder
|
2.6%
1/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
2.4%
1/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
4.2%
1/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
7.7%
1/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.2%
1/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respitatory, thoracic and mediastinal
|
2.6%
1/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
2.4%
1/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
4.2%
1/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
2.4%
1/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
General disorders
general disorders
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
2.4%
1/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
4.2%
1/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Vascular disorders
Vascular disorders
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
5.3%
1/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
Other adverse events
| Measure |
Luminate 1.0mg Group
n=39 participants at risk
Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 1.0mg
|
Luminate 2.0mg Group
n=33 participants at risk
Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 2.0mg
|
Luminate 3.0mg Group
n=42 participants at risk
Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 3.0mg
|
Avastin® Group
n=24 participants at risk
Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.
Avastin
|
Avastin Then Luminate 1.0 mg IVT + Sham Injection
n=19 participants at risk
Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Luminate 1.0mg
Avastin
|
Avastin Then Luminate 0.5 mg IVT + Sham Injection
n=17 participants at risk
Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Avastin
Luminate 0.5mg
|
Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT
n=13 participants at risk
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Luminate 1.0mg
Avastin
|
Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT
n=16 participants at risk
Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Avastin
Luminate 0.5mg
|
Avastin 1.25 mg + Sham IVT
n=15 participants at risk
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN
Luminate 0.5mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and Lymphatic
|
5.1%
2/39 • Number of events 2 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Cardiac disorders
Cardiac disorders
|
7.7%
3/39 • Number of events 4 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
10.5%
2/19 • Number of events 2 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Eye disorders
eye disorders
|
43.6%
17/39 • Number of events 18 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
27.3%
9/33 • Number of events 9 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
26.2%
11/42 • Number of events 20 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
29.2%
7/24 • Number of events 19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
31.6%
6/19 • Number of events 7 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
5.9%
1/17 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
30.8%
4/13 • Number of events 9 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
31.2%
5/16 • Number of events 6 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.7%
1/15 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Gastrointestinal disorders
gastrointestinal disorders
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
9.1%
3/33 • Number of events 3 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
9.5%
4/42 • Number of events 4 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
7.7%
1/13 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.7%
1/15 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Infections and infestations
infections and infestations
|
15.4%
6/39 • Number of events 6 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
15.2%
5/33 • Number of events 5 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
9.5%
4/42 • Number of events 5 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
12.5%
3/24 • Number of events 3 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
5.3%
1/19 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
11.8%
2/17 • Number of events 2 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
15.4%
2/13 • Number of events 3 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
12.8%
5/39 • Number of events 5 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
9.1%
3/33 • Number of events 3 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
12.5%
3/24 • Number of events 3 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
5.9%
1/17 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Investigations
Investigations
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
9.5%
4/42 • Number of events 4 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Metabolism and nutrition disorders
Metabolism and nutritional disorders
|
5.1%
2/39 • Number of events 2 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
9.5%
4/42 • Number of events 5 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
8.3%
2/24 • Number of events 3 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
5.9%
1/17 • Number of events 2 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal and connective tissue
|
5.1%
2/39 • Number of events 3 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.1%
2/33 • Number of events 2 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
5.3%
1/19 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Nervous system disorders
Nervous system disorders
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.7%
1/15 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Psychiatric disorders
psychiatric disorders
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
7.7%
1/13 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
8.3%
2/24 • Number of events 2 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissue disorders
|
0.00%
0/39 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/33 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
4.8%
2/42 • Number of events 2 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/19 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
7.7%
1/13 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/16 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
|
Vascular disorders
Vascular disorders
|
10.3%
4/39 • Number of events 4 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.1%
2/33 • Number of events 2 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/42 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/24 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
5.3%
1/19 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/17 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/13 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
0.00%
0/15 • The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator will submit to Sponsor a copy of the proposed publication or presentation and the name of the scientific journal or forum to which it will be submitted- at least ninety (90) days prior to the submission.Investigator shall comply with Sponsor's request to delete references to Confidential Information,in any such paper or presentation and agrees to withhold publication or presentation of same for an additional ninety (90) days in order to permit Sponsor to obtain patent protection.
- Publication restrictions are in place
Restriction type: OTHER