Trial Outcomes & Findings for Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) (NCT NCT00943072)
NCT ID: NCT00943072
Last Updated: 2013-05-27
Results Overview
Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
189 participants
Primary outcome timeframe
Baseline and at Week 24
Results posted on
2013-05-27
Participant Flow
The study was conducted at 55 study centers in the United States, Canada, Columbia, India, and Israel. The recruitment period occurred between 08 Jul 2009 and 29 Apr 2010.
273 participants were screened, 189 randomized, and 188 were included in the Safety Analysis Set (SAF). The Full Analysis Set (FAS) included 187 participants with at least one post-baseline assessment.
Participant milestones
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk.
|
Sham Treatment
Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given.
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
74
|
|
Overall Study
Participants Received Treatment
|
114
|
74
|
|
Overall Study
Full Analysis Set (FAS) Population
|
114
|
73
|
|
Overall Study
COMPLETED
|
110
|
60
|
|
Overall Study
NOT COMPLETED
|
5
|
14
|
Reasons for withdrawal
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk.
|
Sham Treatment
Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Baseline characteristics by cohort
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
n=114 Participants
Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
|
Sham Treatment
n=74 Participants
Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
65.5 years
STANDARD_DEVIATION 13.57 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 14.22 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 13.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Retinal Thickness by Optical Coherence Tomography (OCT)
|
661.7 microns
STANDARD_DEVIATION 237.37 • n=5 Participants
|
678.4 microns
STANDARD_DEVIATION 248.66 • n=7 Participants
|
668.1 microns
STANDARD_DEVIATION 241.23 • n=5 Participants
|
|
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score
|
77.67 scores on a scale
STANDARD_DEVIATION 15.96 • n=5 Participants
|
78.01 scores on a scale
STANDARD_DEVIATION 16.26 • n=7 Participants
|
77.81 scores on a scale
STANDARD_DEVIATION 16.04 • n=5 Participants
|
|
Baseline Intraocular Pressure
|
15.1 millimeters of mercury (mmHg)
STANDARD_DEVIATION 3.26 • n=5 Participants
|
15.0 millimeters of mercury (mmHg)
STANDARD_DEVIATION 2.83 • n=7 Participants
|
15.1 millimeters of mercury (mmHg)
STANDARD_DEVIATION 3.09 • n=5 Participants
|
|
Number of Participants with Retinal Perfusion at Baseline
Perfused
|
77 participants
n=5 Participants
|
50 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Number of Participants with Retinal Perfusion at Baseline
Non-Perfused
|
17 participants
n=5 Participants
|
12 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Number of Participants with Retinal Perfusion at Baseline
Indeterminate
|
20 participants
n=5 Participants
|
12 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Baseline Best Corrected Visual Acuity (BCVA) Letter Score
|
50.7 letters correctly read
STANDARD_DEVIATION 13.90 • n=5 Participants
|
48.7 letters correctly read
STANDARD_DEVIATION 14.41 • n=7 Participants
|
49.9 letters correctly read
STANDARD_DEVIATION 14.10 • n=5 Participants
|
|
Time Since Central Retinal Vein Occlusion (CRVO) Diagnosis
</= 2 Months
|
64 participants
n=5 Participants
|
53 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Time Since Central Retinal Vein Occlusion (CRVO) Diagnosis
> 2 Months
|
49 participants
n=5 Participants
|
21 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Time Since Central Retinal Vein Occlusion (CRVO) Diagnosis
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and at Week 24Population: Full Analysis Set
Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
n=114 Participants
Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
|
Sham Treatment
n=73 Participants
Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
|
|---|---|---|
|
Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score
|
64 percentage of participants
|
9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and at Week 24Population: Full Analysis Set
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
n=114 Participants
Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
|
Sham Treatment
n=73 Participants
Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
|
|---|---|---|
|
Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)
|
17.3 letters correctly read
Standard Deviation 12.78
|
-4.0 letters correctly read
Standard Deviation 17.96
|
SECONDARY outcome
Timeframe: Baseline and at Week 24Population: Full Analysis Set
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
n=114 Participants
Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
|
Sham Treatment
n=73 Participants
Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
|
|---|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
|
-457.2 microns
Standard Deviation 238.21
|
-144.8 microns
Standard Deviation 291.07
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
n=114 Participants
Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
|
Sham Treatment
n=73 Participants
Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
|
|---|---|---|
|
Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks
Any neovascularization
|
0 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks
Anterior segment neovascularization
|
0 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks
Neovascularization of the optic disc (NVD)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks
Neovascularization elsewhere in the fundus (NVE)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and at Week 24The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
n=114 Participants
Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
|
Sham Treatment
n=73 Participants
Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
|
|---|---|---|
|
Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)
|
7.2 scores on a scale
Standard Deviation 12.11
|
0.8 scores on a scale
Standard Deviation 9.79
|
Adverse Events
Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24)
Serious events: 6 serious events
Other events: 57 other events
Deaths: 0 deaths
Sham Treatment (Baseline to Week 24)
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
IAI to IAI (Week 24 to Week 100)
Serious events: 20 serious events
Other events: 76 other events
Deaths: 0 deaths
Sham Treatment to IAI (Week 24 to Week 100)
Serious events: 14 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24)
n=114 participants at risk
Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 20. Participants were observed until Week 24.
Participants in the safety population were at risk.
|
Sham Treatment (Baseline to Week 24)
n=74 participants at risk
Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
|
IAI to IAI (Week 24 to Week 100)
n=110 participants at risk
Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk.
|
Sham Treatment to IAI (Week 24 to Week 100)
n=60 participants at risk
Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma stage IV
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Cataract
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.8%
2/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Dry eye
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Eye irritation
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Eye pain
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Glaucoma
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
2.7%
2/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Iris neovascularisation
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
2.7%
2/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Macular oedema
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Maculopathy
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Optic disc vascular disorder
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal artery occlusion
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal exudates
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal tear
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Visual acuity reduced
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.8%
2/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
General disorders
Adhesion
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
General disorders
Chest discomfort
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
General disorders
Chest pain
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
General disorders
Generalised oedema
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.8%
2/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Bronchitis viral
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Endophthalmitis
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Herpes oesophagitis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Influenza
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.0%
3/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.8%
2/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Investigations
Blood urine present
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Investigations
Protein urine present
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
3.3%
2/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Nervous system disorders
Dementia
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.4%
1/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.88%
1/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
1.7%
1/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.91%
1/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
Other adverse events
| Measure |
Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24)
n=114 participants at risk
Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 20. Participants were observed until Week 24.
Participants in the safety population were at risk.
|
Sham Treatment (Baseline to Week 24)
n=74 participants at risk
Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
|
IAI to IAI (Week 24 to Week 100)
n=110 participants at risk
Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk.
|
Sham Treatment to IAI (Week 24 to Week 100)
n=60 participants at risk
Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given.
|
|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
8.8%
10/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.4%
4/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
11.8%
13/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
15.0%
9/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Cataract
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.5%
6/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
12.7%
14/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
6.7%
4/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Dry eye
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
6.7%
4/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Eye irritation
|
5.3%
6/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Eye pain
|
14.0%
16/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.4%
4/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
8.2%
9/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
6.7%
4/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Iris neovascularisation
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.4%
4/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
6.7%
4/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Macular oedema
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
18.2%
20/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Maculopathy
|
8.8%
10/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.5%
6/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Optic disc vascular disorder
|
7.0%
8/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.5%
6/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
8.3%
5/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal exudates
|
6.1%
7/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
8.3%
5/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.5%
6/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
6.7%
4/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
20.0%
12/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Retinal vascular disorder
|
5.3%
6/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.4%
4/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
7.3%
8/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Visual acuity reduced
|
6.1%
7/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
16.2%
12/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
24.5%
27/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
13.3%
8/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
6.8%
5/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
7.3%
8/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Eye disorders
Vitreous floaters
|
5.3%
6/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Influenza
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
6.4%
7/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.4%
4/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.5%
6/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
6/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
5.5%
6/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
6.7%
4/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Investigations
Blood urine present
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
6.7%
4/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
6.7%
4/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
|
Investigations
Protein urine present
|
0.00%
0/114 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/74 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
0.00%
0/110 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
8.3%
5/60 • Baseline to Week 24; Week 24 to Week 100
Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals
Phone: 914 847 5385
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI, after completion of the trial and multi-center publication, is that the sponsor can review results communications prior to public release \& may have the right to embargo communications regarding results for a period between 60 \& 180 days from the time submitted to the sponsor for review; provided that the sponsor can remove confidential/proprietary information. The sponsor cannot require other changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER