Trial Outcomes & Findings for Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease (NCT NCT04429503)
NCT ID: NCT04429503
Last Updated: 2025-08-08
Results Overview
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
660 participants
Primary outcome timeframe
Baseline, Week 48
Results posted on
2025-08-08
Participant Flow
A total of 970 participants were screened and 660 participants were randomized, of whom 658 participants received at least 1 dose of study treatment in the study eye. Fellow eye treatment was allowed with 2 mg aflibercept at the investigator's discretion for indications approved by governing authorities. The treated fellow eye was not considered an additional study eye. Only one study eye per participant was analyzed within the study.
Participant milestones
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
2q8/HD Aflibercept (Extension)
Participants receiving aflibercept 2q8 switched to HD in the extension phase
|
HDq12 Aflibercept (Extension)
Participants continued to receive HDq12 aflibercept during the extension phase
|
HDq16 Aflibercept (Extension)
Participants continued to receive HDq16 aflibercept during the extension phase
|
|---|---|---|---|---|---|---|
|
Main Study (Up to Wk 96)
STARTED
|
167
|
329
|
164
|
0
|
0
|
0
|
|
Main Study (Up to Wk 96)
Treated
|
167
|
328
|
163
|
0
|
0
|
0
|
|
Main Study (Up to Wk 96)
Completed Week 48
|
157
|
300
|
156
|
0
|
0
|
0
|
|
Main Study (Up to Wk 96)
Completed Week 60
|
155
|
289
|
152
|
0
|
0
|
0
|
|
Main Study (Up to Wk 96)
COMPLETED
|
139
|
256
|
139
|
0
|
0
|
0
|
|
Main Study (Up to Wk 96)
NOT COMPLETED
|
28
|
73
|
25
|
0
|
0
|
0
|
|
Extension Phase (Wk 96 to Wk 156)
STARTED
|
0
|
0
|
0
|
70
|
130
|
65
|
|
Extension Phase (Wk 96 to Wk 156)
COMPLETED
|
0
|
0
|
0
|
58
|
103
|
49
|
|
Extension Phase (Wk 96 to Wk 156)
NOT COMPLETED
|
0
|
0
|
0
|
12
|
27
|
16
|
Reasons for withdrawal
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
2q8/HD Aflibercept (Extension)
Participants receiving aflibercept 2q8 switched to HD in the extension phase
|
HDq12 Aflibercept (Extension)
Participants continued to receive HDq12 aflibercept during the extension phase
|
HDq16 Aflibercept (Extension)
Participants continued to receive HDq16 aflibercept during the extension phase
|
|---|---|---|---|---|---|---|
|
Main Study (Up to Wk 96)
Non-compliance with protocol by the subject
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Main Study (Up to Wk 96)
Adverse Event
|
1
|
9
|
2
|
0
|
0
|
0
|
|
Main Study (Up to Wk 96)
Decision by the investigator/sponsor
|
2
|
9
|
3
|
0
|
0
|
0
|
|
Main Study (Up to Wk 96)
Withdrawal by Subject
|
9
|
17
|
8
|
0
|
0
|
0
|
|
Main Study (Up to Wk 96)
Lost to Follow-up
|
5
|
19
|
7
|
0
|
0
|
0
|
|
Main Study (Up to Wk 96)
Death
|
9
|
18
|
5
|
0
|
0
|
0
|
|
Extension Phase (Wk 96 to Wk 156)
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Extension Phase (Wk 96 to Wk 156)
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Extension Phase (Wk 96 to Wk 156)
Decision by the Investigator/Sponsor
|
0
|
0
|
0
|
0
|
3
|
2
|
|
Extension Phase (Wk 96 to Wk 156)
Withdrawal by Subject
|
0
|
0
|
0
|
5
|
10
|
5
|
|
Extension Phase (Wk 96 to Wk 156)
Lost to Follow-up
|
0
|
0
|
0
|
3
|
6
|
6
|
|
Extension Phase (Wk 96 to Wk 156)
Death
|
0
|
0
|
0
|
2
|
7
|
2
|
Baseline Characteristics
Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
Baseline characteristics by cohort
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=167 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=328 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
Total
n=658 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.0 Years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
62.1 Years
STANDARD_DEVIATION 11.13 • n=7 Participants
|
61.9 Years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
62.3 Years
STANDARD_DEVIATION 10.41 • n=4 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
257 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
401 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
133 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
525 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
112 Participants
n=5 Participants
|
231 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
471 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Best Corrected Visual Acuity (BCVA) in the Study Eye
|
61.5 Letters
STANDARD_DEVIATION 11.22 • n=5 Participants
|
63.6 Letters
STANDARD_DEVIATION 10.10 • n=7 Participants
|
61.4 Letters
STANDARD_DEVIATION 11.76 • n=5 Participants
|
62.5 Letters
STANDARD_DEVIATION 10.86 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Only one study eye per participant was analyzed within the study.
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=167 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=328 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48
|
8.67 Letters
Standard Error 0.73
|
8.10 Letters
Standard Error 0.61
|
7.23 Letters
Standard Error 0.71
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Only one study eye per participant was analyzed within the study,
The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=158 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=310 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=153 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Percentage of Participants With a ≥2 Step Improvement From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Score at Week 48
|
26.6 Percentage of Participants
|
29.0 Percentage of Participants
|
19.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). Only one study eye per participant was analyzed within the study
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=165 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=326 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline at Week 48
|
23.0 Percentage of Participants
|
18.7 Percentage of Participants
|
16.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 48Population: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Only one study eye per participant was analyzed within the study,
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=165 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=326 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Percentage of Participants With BCVA ≥69 Letters at Week 48
|
63.0 Percentage of Participants
|
65.3 Percentage of Participants
|
62.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 48Population: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)
Retinal fluid status was evaluated using spectral domain optical coherence tomography (SD-OCT) on the study eye.
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=165 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=325 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=162 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Percentage of Participants Without Fluid at Foveal Center at Week 48
|
54.5 Percentage of Participants
|
58.5 Percentage of Participants
|
43.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized). Only one study eye per participant was analyzed within the study.
Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=167 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=328 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 48
|
-164.85 Microns
Standard Error 8.79
|
-176.77 Microns
Standard Error 5.73
|
-148.84 Microns
Standard Error 9.45
|
SECONDARY outcome
Timeframe: At Week 48Population: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)
Leakage is the release of fluorescein dye from diseased retinal vessels.
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=162 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=303 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=152 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Percentage of Participants Without Leakage on Fluorescein Angiography (FA) at Week 48
|
2.5 Percentage of Participants
|
7.6 Percentage of Participants
|
0.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)
Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=167 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=328 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Total Score at Week 48
|
2.82 Score on a Scale
Standard Error 1.10
|
4.06 Score on a Scale
Standard Error 0.80
|
2.94 Score on a Scale
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Through Week 48Population: Pharmacokinetic analysis set (PKAS): All treated participants who received any amount of study drug and had at least 1 non-missing free or bound aflibercept measurement following the first dose of study drug as applicable. The PKAS is based on the actual treatment received (as treated) rather than as randomized.
Concentrations of Free Aflibercept in Plasma by Time and Treatment Group
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=167 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=328 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Systemic Pharmacokinetics (PK) of Aflibercept as Assessed by Plasma Concentrations Through Week 48
|
0.00102 milligram/Litre (mg/L)
Standard Deviation 0.00580
|
0.0111 milligram/Litre (mg/L)
Standard Deviation 0.0157
|
0.00105 milligram/Litre (mg/L)
Standard Deviation 0.00477
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full Analysis Set (FAS) - for participants who had both baseline BCVA and week 48 BCVA; Only one study eye per participant was analyzed within the study
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per Statistical Analysis Plan (SAP) Version 2.0 Appendix 10.9 for US Only)
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=153 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=291 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=154 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Change From Baseline in BCVA in the Study Eye in Participants With Both Baseline and Week 48 BCVA
|
9.11 Letters
Standard Deviation 8.94
|
9.14 Letters
Standard Deviation 8.35
|
9.11 Letters
Standard Deviation 7.30
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full Analysis Set (FAS) - for participants who had both BCVA at 8 weeks post initial treatment and week 48 BCVA; Only one study eye per participant was analyzed within the study
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per SAP Version 2.0 Appendix 10.9 for US Only)
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=152 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=282 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=153 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Change From 8-weeks Post Initial Treatment Phase in BCVA in the Study Eye in Participants With Both 8-weeks Post Initial Treatment Phase BCVA and Week 48 BCVA
|
1.63 Letters
Standard Deviation 6.65
|
1.68 Letters
Standard Deviation 5.54
|
1.64 Letters
Standard Deviation 4.75
|
SECONDARY outcome
Timeframe: Baseline, Week 60Population: FAS: All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Here, Number of Participants Analyzed = Number of participants with week 60 data. Only one study eye per participant was analyzed within the study
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=167 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=328 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Change From Baseline in BCVA (Region-specific Analysis) in the Study Eye at Week 60
|
9.40 Letters
Standard Error 0.77
|
8.52 Letters
Standard Error 0.63
|
7.64 Letters
Standard Error 0.75
|
SECONDARY outcome
Timeframe: Through Week 96Population: ADA analysis set (AAS): All treated participants who received any amount of study drug and had at least 1 non-missing anti-aflibercept antibody result following the first dose of study drug. The AAS is based on the actual treatment received (as treated) rather than as randomized
Number of participants with pre-existing immunoreactivity and treatment-emergent ADA response reported
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=151 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=289 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=150 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Assessment of Immunogenicity to Aflibercept by Measuring the Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response Through Week 96
Pre-existing Immunoreactivity
|
4 Participants
|
11 Participants
|
2 Participants
|
|
Assessment of Immunogenicity to Aflibercept by Measuring the Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response Through Week 96
Treatment-Emergent
|
2 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Through Week 96Population: Safety analysis set (SAF): All randomized participants who received any study treatment; it was based on the treatment received (as treated)
A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=167 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=328 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Through Week 96
|
134 Participants
|
277 Participants
|
143 Participants
|
SECONDARY outcome
Timeframe: Through Week 96Population: Safety analysis set (SAF): All randomized participants who received any study treatment; it was based on the treatment received (as treated)
A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=167 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=328 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Number of Participants With Any Serious TEAE Through Week 96
|
46 Participants
|
81 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Through Week 156Population: Extension Safety Analysis Set (eSAF): All participants in the SAF who enrolled in the extension phase and completed the extension baseline visit.
TEAEs are defined as AEs starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days or week 156 visit, whichever was later.
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=70 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=130 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=65 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Number of Participants With Any TEAE Through Week 156
|
64 Participants
|
122 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Through Week 156Population: Extension Safety Analysis Set (eSAF): All participants in the SAF who enrolled in the extension phase and completed the extension baseline visit.
Outcome measures
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=70 Participants
Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses
|
High-dose (HD) Aflibercept Every 12 Weeks (HDq12)
n=130 Participants
Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses
|
HD Aflibercept Every 16 Weeks (HDq16)
n=65 Participants
Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses
|
|---|---|---|---|
|
Number of Participants With Any Serious TEAE Through Week 156
|
27 Participants
|
41 Participants
|
22 Participants
|
Adverse Events
Aflibercept 2 mg Every 8 Weeks (2q8)
Serious events: 46 serious events
Other events: 98 other events
Deaths: 9 deaths
HD Aflibercept Every 12 Weeks (HDq12)
Serious events: 84 serious events
Other events: 190 other events
Deaths: 18 deaths
HD Aflibercept Every 16 Weeks (HDq16)
Serious events: 45 serious events
Other events: 116 other events
Deaths: 5 deaths
2q8/HD Aflibercept (Extension)
Serious events: 27 serious events
Other events: 50 other events
Deaths: 2 deaths
HDq12 Aflibercept (Extension)
Serious events: 46 serious events
Other events: 99 other events
Deaths: 7 deaths
HDq16 Aflibercept (Extension)
Serious events: 23 serious events
Other events: 50 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=167 participants at risk
(baseline through week 96)
|
HD Aflibercept Every 12 Weeks (HDq12)
n=328 participants at risk
(baseline through week 96)
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 participants at risk
(baseline through week 96)
|
2q8/HD Aflibercept (Extension)
n=70 participants at risk
Participants receiving aflibercept 2q8 switched to HD in the extension phase (week 96 through week 156)
|
HDq12 Aflibercept (Extension)
n=130 participants at risk
Participants continued to receive HDq12 aflibercept during the extension phase (week 96 through 156)
|
HDq16 Aflibercept (Extension)
n=65 participants at risk
Participants continued to receive HDq16 aflibercept during the extension phase (week 96 through 156)
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
COVID-19
|
0.00%
0/167 • From first study treatment through week 156
|
1.8%
6/328 • Number of events 6 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
2.3%
3/130 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Pneumonia
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
1.8%
6/328 • Number of events 6 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
3.1%
4/130 • Number of events 4 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Infections and infestations
COVID-19 pneumonia
|
1.8%
3/167 • Number of events 3 • From first study treatment through week 156
|
0.91%
3/328 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Bronchitis
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Citrobacter sepsis
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Diabetic gangrene
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Localised infection
|
0.00%
0/167 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
2.3%
3/130 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/167 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
3.1%
4/130 • Number of events 4 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Osteomyelitis acute
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Cellulitis
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 2 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
3.1%
2/65 • Number of events 2 • From first study treatment through week 156
|
|
Infections and infestations
Gangrene
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Infections and infestations
Sepsis
|
2.4%
4/167 • Number of events 4 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
4.3%
3/70 • Number of events 3 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
3/167 • Number of events 4 • From first study treatment through week 156
|
1.5%
5/328 • Number of events 5 • From first study treatment through week 156
|
1.8%
3/163 • Number of events 3 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
3.1%
4/130 • Number of events 4 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Cardiac disorders
Cardiac arrest
|
1.8%
3/167 • Number of events 3 • From first study treatment through week 156
|
0.91%
3/328 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Cardiac failure
|
0.60%
1/167 • Number of events 2 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Cardiac disorders
Acute left ventricular failure
|
1.8%
3/167 • Number of events 3 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
3.0%
10/328 • Number of events 10 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 2 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Angina unstable
|
0.60%
1/167 • Number of events 2 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 2 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
0.91%
3/328 • Number of events 3 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 2 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/167 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/167 • From first study treatment through week 156
|
0.91%
3/328 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Cardiac failure congestive
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
2.3%
3/130 • Number of events 3 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
2.1%
7/328 • Number of events 7 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
3.1%
4/130 • Number of events 4 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/167 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Renal and urinary disorders
End stage renal disease
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.91%
3/328 • Number of events 3 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 2 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/167 • From first study treatment through week 156
|
0.91%
3/328 • Number of events 3 • From first study treatment through week 156
|
3.1%
5/163 • Number of events 5 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
2.3%
3/130 • Number of events 3 • From first study treatment through week 156
|
3.1%
2/65 • Number of events 2 • From first study treatment through week 156
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Syncope
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/167 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Vascular disorders
Haematoma
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Vascular disorders
Hypertensive emergency
|
0.60%
1/167 • Number of events 3 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Vascular disorders
Hypertension
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Vascular disorders
Hypotension
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Vascular disorders
Orthostatic hypotension
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Vascular disorders
Thrombosis
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
General disorders
Chest pain
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.91%
3/328 • Number of events 3 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
General disorders
Death
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.91%
3/328 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
General disorders
Oedema peripheral
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
General disorders
Sudden death
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/167 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 2 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Blood and lymphatic system disorders
Anaemia
|
0.60%
1/167 • Number of events 2 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 2 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Investigations
Blood glucose increased
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/167 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
1.8%
3/163 • Number of events 3 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
3.1%
2/65 • Number of events 2 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Psychiatric disorders
Stress
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Surgical and medical procedures
Thrombosis prophylaxis
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Hepatobiliary disorders
Bile duct stone
|
0.60%
1/167 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Hepatobiliary disorders
Cholecystitis
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Cataract Fellow Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Diabetic retinopathy Fellow Eye
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.91%
3/328 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Retinal haemorrhage Fellow Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Vitreous haemorrhage Fellow Eye
|
1.2%
2/167 • Number of events 3 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 3 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Retinal artery occlusion Fellow Eye
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Tractional retinal detachment Fellow Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Eye disorders
Cataract subcapsular Study Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Retinal detachment Study Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Ulcerative keratitis Study Eye
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Vitreous haemorrhage Study Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Investigations
Intraocular pressure increased Study Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Urosepsis
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/167 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/167 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 4 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Infections and infestations
Wound infection
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.60%
1/167 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Epiretinal membrane Fellow Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Cardiac disorders
Ventricular tachycardia
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Septic shock
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Cellulitis gangrenous
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Cystitis
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Infections and infestations
Pyelonephritis acute
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 2 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile squamous cell carcinoma
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Embolic stroke
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Ischaemic stroke
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Presyncope
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Nervous system disorders
Seizure
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
General disorders
Asthenia
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/167 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 2 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
3.1%
4/130 • Number of events 4 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Product Issues
Device failure
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Psychiatric disorders
Mental status changes
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Immune system disorders
Hypersensitivity
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Reproductive system and breast disorders
Prostatitis
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Investigations
Intraocular pressure increased Fellow Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Cataract nuclear Study Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.30%
1/328 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Cataract Study Eye
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Retinal neovascularisation Study Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Endophthalmitis Study Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Musculoskeletal and connective tissue disorders
Vertebral lesion
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Investigations
Blood pressure increased
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Eye disorders
Ulcerative keratitis Fellow Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Eye disorders
Retinal tear Study Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Nervous system disorders
Occipital lobe stroke
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
General disorders
Organ failure
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/167 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
|
Infections and infestations
Post procedural infection
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
0.00%
0/163 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
0.00%
0/65 • From first study treatment through week 156
|
Other adverse events
| Measure |
Aflibercept 2 mg Every 8 Weeks (2q8)
n=167 participants at risk
(baseline through week 96)
|
HD Aflibercept Every 12 Weeks (HDq12)
n=328 participants at risk
(baseline through week 96)
|
HD Aflibercept Every 16 Weeks (HDq16)
n=163 participants at risk
(baseline through week 96)
|
2q8/HD Aflibercept (Extension)
n=70 participants at risk
Participants receiving aflibercept 2q8 switched to HD in the extension phase (week 96 through week 156)
|
HDq12 Aflibercept (Extension)
n=130 participants at risk
Participants continued to receive HDq12 aflibercept during the extension phase (week 96 through 156)
|
HDq16 Aflibercept (Extension)
n=65 participants at risk
Participants continued to receive HDq16 aflibercept during the extension phase (week 96 through 156)
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
9.0%
15/167 • Number of events 16 • From first study treatment through week 156
|
12.2%
40/328 • Number of events 41 • From first study treatment through week 156
|
16.0%
26/163 • Number of events 27 • From first study treatment through week 156
|
8.6%
6/70 • Number of events 6 • From first study treatment through week 156
|
14.6%
19/130 • Number of events 22 • From first study treatment through week 156
|
23.1%
15/65 • Number of events 18 • From first study treatment through week 156
|
|
Vascular disorders
Hypertension
|
13.2%
22/167 • Number of events 31 • From first study treatment through week 156
|
10.7%
35/328 • Number of events 38 • From first study treatment through week 156
|
19.0%
31/163 • Number of events 34 • From first study treatment through week 156
|
8.6%
6/70 • Number of events 10 • From first study treatment through week 156
|
16.2%
21/130 • Number of events 22 • From first study treatment through week 156
|
20.0%
13/65 • Number of events 13 • From first study treatment through week 156
|
|
Eye disorders
Cataract Fellow Eye
|
4.8%
8/167 • Number of events 8 • From first study treatment through week 156
|
5.2%
17/328 • Number of events 17 • From first study treatment through week 156
|
8.6%
14/163 • Number of events 14 • From first study treatment through week 156
|
10.0%
7/70 • Number of events 7 • From first study treatment through week 156
|
13.8%
18/130 • Number of events 19 • From first study treatment through week 156
|
12.3%
8/65 • Number of events 8 • From first study treatment through week 156
|
|
Eye disorders
Cataract Study Eye
|
3.0%
5/167 • Number of events 5 • From first study treatment through week 156
|
5.5%
18/328 • Number of events 19 • From first study treatment through week 156
|
11.0%
18/163 • Number of events 18 • From first study treatment through week 156
|
11.4%
8/70 • Number of events 8 • From first study treatment through week 156
|
13.8%
18/130 • Number of events 18 • From first study treatment through week 156
|
15.4%
10/65 • Number of events 10 • From first study treatment through week 156
|
|
Eye disorders
Vitreous floaters Study Eye
|
3.6%
6/167 • Number of events 6 • From first study treatment through week 156
|
5.8%
19/328 • Number of events 20 • From first study treatment through week 156
|
4.3%
7/163 • Number of events 8 • From first study treatment through week 156
|
4.3%
3/70 • Number of events 3 • From first study treatment through week 156
|
6.2%
8/130 • Number of events 9 • From first study treatment through week 156
|
6.2%
4/65 • Number of events 4 • From first study treatment through week 156
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
5/167 • Number of events 5 • From first study treatment through week 156
|
3.7%
12/328 • Number of events 12 • From first study treatment through week 156
|
5.5%
9/163 • Number of events 9 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
3.8%
5/130 • Number of events 5 • From first study treatment through week 156
|
4.6%
3/65 • Number of events 3 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
3/167 • Number of events 3 • From first study treatment through week 156
|
1.8%
6/328 • Number of events 6 • From first study treatment through week 156
|
5.5%
9/163 • Number of events 12 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
3.1%
2/65 • Number of events 2 • From first study treatment through week 156
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
9/167 • Number of events 11 • From first study treatment through week 156
|
6.4%
21/328 • Number of events 24 • From first study treatment through week 156
|
6.1%
10/163 • Number of events 12 • From first study treatment through week 156
|
7.1%
5/70 • Number of events 7 • From first study treatment through week 156
|
12.3%
16/130 • Number of events 21 • From first study treatment through week 156
|
6.2%
4/65 • Number of events 7 • From first study treatment through week 156
|
|
Infections and infestations
Urinary tract infection
|
6.0%
10/167 • Number of events 12 • From first study treatment through week 156
|
2.7%
9/328 • Number of events 13 • From first study treatment through week 156
|
4.3%
7/163 • Number of events 8 • From first study treatment through week 156
|
5.7%
4/70 • Number of events 6 • From first study treatment through week 156
|
6.2%
8/130 • Number of events 10 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Eye disorders
Conjunctival haemorrhage Study Eye
|
3.6%
6/167 • Number of events 7 • From first study treatment through week 156
|
5.5%
18/328 • Number of events 18 • From first study treatment through week 156
|
4.9%
8/163 • Number of events 9 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 3 • From first study treatment through week 156
|
3.1%
4/130 • Number of events 5 • From first study treatment through week 156
|
4.6%
3/65 • Number of events 4 • From first study treatment through week 156
|
|
Cardiac disorders
Coronary artery disease
|
2.4%
4/167 • Number of events 4 • From first study treatment through week 156
|
1.5%
5/328 • Number of events 5 • From first study treatment through week 156
|
0.61%
1/163 • Number of events 1 • From first study treatment through week 156
|
5.7%
4/70 • Number of events 4 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Eye disorders
Eye pain Study Eye
|
2.4%
4/167 • Number of events 4 • From first study treatment through week 156
|
3.0%
10/328 • Number of events 10 • From first study treatment through week 156
|
1.8%
3/163 • Number of events 3 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
2.3%
3/130 • Number of events 3 • From first study treatment through week 156
|
6.2%
4/65 • Number of events 5 • From first study treatment through week 156
|
|
Eye disorders
Punctate keratitis Study Eye
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
1.5%
5/328 • Number of events 5 • From first study treatment through week 156
|
4.3%
7/163 • Number of events 7 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
2.3%
3/130 • Number of events 3 • From first study treatment through week 156
|
7.7%
5/65 • Number of events 5 • From first study treatment through week 156
|
|
Eye disorders
Retinal haemorrhage Study Eye
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
0.00%
0/328 • From first study treatment through week 156
|
3.7%
6/163 • Number of events 7 • From first study treatment through week 156
|
1.4%
1/70 • Number of events 1 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
7.7%
5/65 • Number of events 6 • From first study treatment through week 156
|
|
Eye disorders
Vision blurred Study Eye
|
3.0%
5/167 • Number of events 5 • From first study treatment through week 156
|
1.2%
4/328 • Number of events 4 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 2 • From first study treatment through week 156
|
5.7%
4/70 • Number of events 4 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
3.1%
2/65 • Number of events 2 • From first study treatment through week 156
|
|
Eye disorders
Visual acuity reduced Study Eye
|
2.4%
4/167 • Number of events 4 • From first study treatment through week 156
|
1.8%
6/328 • Number of events 9 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 2 • From first study treatment through week 156
|
5.7%
4/70 • Number of events 4 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Eye disorders
Visual impairment Study Eye
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
1.8%
6/328 • Number of events 6 • From first study treatment through week 156
|
1.8%
3/163 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
3.1%
4/130 • Number of events 4 • From first study treatment through week 156
|
6.2%
4/65 • Number of events 4 • From first study treatment through week 156
|
|
Eye disorders
Vitreous detachment Study Eye
|
4.2%
7/167 • Number of events 7 • From first study treatment through week 156
|
4.9%
16/328 • Number of events 16 • From first study treatment through week 156
|
3.1%
5/163 • Number of events 5 • From first study treatment through week 156
|
4.3%
3/70 • Number of events 3 • From first study treatment through week 156
|
6.2%
8/130 • Number of events 8 • From first study treatment through week 156
|
3.1%
2/65 • Number of events 2 • From first study treatment through week 156
|
|
Eye disorders
Intraocular pressure increased Study Eye
|
4.2%
7/167 • Number of events 13 • From first study treatment through week 156
|
2.7%
9/328 • Number of events 12 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 2 • From first study treatment through week 156
|
7.1%
5/70 • Number of events 15 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
3.1%
2/65 • Number of events 2 • From first study treatment through week 156
|
|
Eye disorders
Diabetic retinal oedema Fellow Eye
|
3.6%
6/167 • Number of events 7 • From first study treatment through week 156
|
4.6%
15/328 • Number of events 17 • From first study treatment through week 156
|
4.9%
8/163 • Number of events 8 • From first study treatment through week 156
|
7.1%
5/70 • Number of events 6 • From first study treatment through week 156
|
6.2%
8/130 • Number of events 8 • From first study treatment through week 156
|
4.6%
3/65 • Number of events 3 • From first study treatment through week 156
|
|
Eye disorders
Punctate keratitis Fellow Eye
|
0.00%
0/167 • From first study treatment through week 156
|
0.91%
3/328 • Number of events 3 • From first study treatment through week 156
|
2.5%
4/163 • Number of events 5 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
0.00%
0/130 • From first study treatment through week 156
|
6.2%
4/65 • Number of events 5 • From first study treatment through week 156
|
|
Eye disorders
Vitreous detachment Fellow Eye
|
4.2%
7/167 • Number of events 7 • From first study treatment through week 156
|
2.1%
7/328 • Number of events 8 • From first study treatment through week 156
|
3.1%
5/163 • Number of events 5 • From first study treatment through week 156
|
4.3%
3/70 • Number of events 3 • From first study treatment through week 156
|
3.1%
4/130 • Number of events 4 • From first study treatment through week 156
|
6.2%
4/65 • Number of events 4 • From first study treatment through week 156
|
|
Eye disorders
Vitreous floaters Fellow Eye
|
2.4%
4/167 • Number of events 4 • From first study treatment through week 156
|
1.2%
4/328 • Number of events 4 • From first study treatment through week 156
|
4.9%
8/163 • Number of events 9 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
2.3%
3/130 • Number of events 3 • From first study treatment through week 156
|
7.7%
5/65 • Number of events 7 • From first study treatment through week 156
|
|
Eye disorders
Vitreous haemorrhage Fellow Eye
|
3.0%
5/167 • Number of events 5 • From first study treatment through week 156
|
2.1%
7/328 • Number of events 10 • From first study treatment through week 156
|
3.7%
6/163 • Number of events 7 • From first study treatment through week 156
|
8.6%
6/70 • Number of events 10 • From first study treatment through week 156
|
6.2%
8/130 • Number of events 11 • From first study treatment through week 156
|
4.6%
3/65 • Number of events 4 • From first study treatment through week 156
|
|
Eye disorders
Diabetic retinopathy Fellow Eye
|
3.0%
5/167 • Number of events 5 • From first study treatment through week 156
|
1.5%
5/328 • Number of events 6 • From first study treatment through week 156
|
5.5%
9/163 • Number of events 9 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
2.3%
3/130 • Number of events 3 • From first study treatment through week 156
|
7.7%
5/65 • Number of events 5 • From first study treatment through week 156
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
2.4%
8/328 • Number of events 8 • From first study treatment through week 156
|
3.7%
6/163 • Number of events 6 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
3.8%
5/130 • Number of events 5 • From first study treatment through week 156
|
6.2%
4/65 • Number of events 4 • From first study treatment through week 156
|
|
General disorders
Pyrexia
|
3.0%
5/167 • Number of events 7 • From first study treatment through week 156
|
1.5%
5/328 • Number of events 6 • From first study treatment through week 156
|
3.7%
6/163 • Number of events 6 • From first study treatment through week 156
|
5.7%
4/70 • Number of events 5 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 3 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Infections and infestations
Influenza
|
3.6%
6/167 • Number of events 6 • From first study treatment through week 156
|
1.5%
5/328 • Number of events 5 • From first study treatment through week 156
|
1.8%
3/163 • Number of events 3 • From first study treatment through week 156
|
7.1%
5/70 • Number of events 6 • From first study treatment through week 156
|
3.8%
5/130 • Number of events 5 • From first study treatment through week 156
|
10.8%
7/65 • Number of events 7 • From first study treatment through week 156
|
|
Infections and infestations
Upper respiratory tract infection
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
2.4%
8/328 • Number of events 8 • From first study treatment through week 156
|
1.8%
3/163 • Number of events 3 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
2.3%
3/130 • Number of events 3 • From first study treatment through week 156
|
7.7%
5/65 • Number of events 5 • From first study treatment through week 156
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
4/167 • Number of events 4 • From first study treatment through week 156
|
0.61%
2/328 • Number of events 3 • From first study treatment through week 156
|
1.2%
2/163 • Number of events 3 • From first study treatment through week 156
|
7.1%
5/70 • Number of events 5 • From first study treatment through week 156
|
0.77%
1/130 • Number of events 1 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 2 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.6%
6/167 • Number of events 7 • From first study treatment through week 156
|
2.4%
8/328 • Number of events 8 • From first study treatment through week 156
|
4.9%
8/163 • Number of events 8 • From first study treatment through week 156
|
5.7%
4/70 • Number of events 5 • From first study treatment through week 156
|
2.3%
3/130 • Number of events 3 • From first study treatment through week 156
|
7.7%
5/65 • Number of events 5 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
3.0%
10/328 • Number of events 10 • From first study treatment through week 156
|
4.3%
7/163 • Number of events 7 • From first study treatment through week 156
|
0.00%
0/70 • From first study treatment through week 156
|
3.8%
5/130 • Number of events 5 • From first study treatment through week 156
|
6.2%
4/65 • Number of events 4 • From first study treatment through week 156
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.2%
2/167 • Number of events 2 • From first study treatment through week 156
|
2.7%
9/328 • Number of events 9 • From first study treatment through week 156
|
3.1%
5/163 • Number of events 5 • From first study treatment through week 156
|
4.3%
3/70 • Number of events 3 • From first study treatment through week 156
|
1.5%
2/130 • Number of events 2 • From first study treatment through week 156
|
6.2%
4/65 • Number of events 4 • From first study treatment through week 156
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
5/167 • Number of events 6 • From first study treatment through week 156
|
3.4%
11/328 • Number of events 12 • From first study treatment through week 156
|
3.1%
5/163 • Number of events 5 • From first study treatment through week 156
|
5.7%
4/70 • Number of events 5 • From first study treatment through week 156
|
3.1%
4/130 • Number of events 4 • From first study treatment through week 156
|
3.1%
2/65 • Number of events 2 • From first study treatment through week 156
|
|
Nervous system disorders
Headache
|
2.4%
4/167 • Number of events 5 • From first study treatment through week 156
|
4.0%
13/328 • Number of events 16 • From first study treatment through week 156
|
2.5%
4/163 • Number of events 4 • From first study treatment through week 156
|
4.3%
3/70 • Number of events 4 • From first study treatment through week 156
|
6.2%
8/130 • Number of events 8 • From first study treatment through week 156
|
1.5%
1/65 • Number of events 1 • From first study treatment through week 156
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.60%
1/167 • Number of events 1 • From first study treatment through week 156
|
1.8%
6/328 • Number of events 6 • From first study treatment through week 156
|
3.7%
6/163 • Number of events 6 • From first study treatment through week 156
|
2.9%
2/70 • Number of events 2 • From first study treatment through week 156
|
3.1%
4/130 • Number of events 5 • From first study treatment through week 156
|
6.2%
4/65 • Number of events 4 • From first study treatment through week 156
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER