Trial Outcomes & Findings for Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME. (NCT NCT02581995)
NCT ID: NCT02581995
Last Updated: 2018-10-10
Results Overview
National eye institute 25-item visual function questionnaire (NEI VFQ-25) is a condition-specific measure which was designed to capture the specific impact of vision loss on health-related quality of life (HRQoL). The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the "NEI VFQ-25 Scoring Algorithm - August 2000". The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.
COMPLETED
PHASE4
560 participants
Baseline, Week 52
2018-10-10
Participant Flow
Study was conducted at multiple study centers in 14 countries, between 19 November 2015 (first participant first visit) and 09 August 2017 (last participant last visit).
Overall, 676 participants were screened. Of them, 116 participants did not complete screening: 100 failed screening; 8 withdrew, 1 had an adverse event, 1 was lost to follow-up and 6 were not assigned to treatment for other reasons. A total of 560 participants were assigned to treatment and 31 participants discontinued the study prematurely.
Participant milestones
| Measure |
Aflibercept
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
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|---|---|
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Overall Study
STARTED
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560
|
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Overall Study
Treated
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560
|
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Overall Study
COMPLETED
|
529
|
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Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Aflibercept
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
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|---|---|
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Overall Study
Unspecified other
|
3
|
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Overall Study
Adverse Event
|
6
|
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Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by participant
|
12
|
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Overall Study
Physician Decision
|
1
|
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Overall Study
Death
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4
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Baseline Characteristics
Safety analysis set (SAF) included all participants who received at least 1 injection of study drug.
Baseline characteristics by cohort
| Measure |
Aflibercept
n=560 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
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|---|---|
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Age, Continuous
|
64.3 years
STANDARD_DEVIATION 9.3 • n=560 Participants • Safety analysis set (SAF) included all participants who received at least 1 injection of study drug.
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Sex: Female, Male
Female
|
224 Participants
n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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Sex: Female, Male
Male
|
336 Participants
n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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|
Race (NIH/OMB)
Asian
|
4 Participants
n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
|
|
Race (NIH/OMB)
Black or African American
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3 Participants
n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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Race (NIH/OMB)
White
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519 Participants
n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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Race (NIH/OMB)
More than one race
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0 Participants
n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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Central Retinal Thickness (CRT)
|
465.08 microns
STANDARD_DEVIATION 136.75 • n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Best Corrected Visual Acuity (BCVA)
|
61.5 score on a scale
STANDARD_DEVIATION 11.0 • n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
NEI VFQ-25 total score
|
70.224 score on a scale
STANDARD_DEVIATION 19.221 • n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline national eye institute visual function questionnaire-25 (NEI VFQ-25) questionnaire.
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NEI VFQ-25 near activities subscale
|
62.967 score on a scale
STANDARD_DEVIATION 23.479 • n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
NEI VFQ-25 distant activities subscale
|
71.964 score on a scale
STANDARD_DEVIATION 23.973 • n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Number of Participants with Diabetic Retinopathy Severity Score (DRSS)
10 - DR absent
|
0 Participants
n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Number of Participants with Diabetic Retinopathy Severity Score (DRSS)
15 - DR questionable
|
2 Participants
n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Number of Participants with Diabetic Retinopathy Severity Score (DRSS)
35 - Mild NPDR
|
144 Participants
n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Number of Participants with Diabetic Retinopathy Severity Score (DRSS)
43 - Moderate NPDR
|
184 Participants
n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Number of Participants with Diabetic Retinopathy Severity Score (DRSS)
47 - Moderately severe NPDR
|
151 Participants
n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Number of Participants with Diabetic Retinopathy Severity Score (DRSS)
53 - Severe NPDR
|
48 Participants
n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Number of Participants with Diabetic Retinopathy Severity Score (DRSS)
61 - Mild PDR
|
8 Participants
n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Number of Participants with Diabetic Retinopathy Severity Score (DRSS)
65 - Moderate PDR
|
8 Participants
n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Number of Participants with Diabetic Retinopathy Severity Score (DRSS)
71 - High-risk PDR
|
2 Participants
n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
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Number of Participants with Diabetic Retinopathy Severity Score (DRSS)
90 - Cannot grade
|
6 Participants
n=553 Participants • FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
|
|
Pre-injection Intraocular Pressure
|
16.2 millimeter of mercury (mmHg)
STANDARD_DEVIATION 3.0 • n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
|
|
Systolic Blood Pressure
|
138.1 millimeter of mercury (mmHg)
STANDARD_DEVIATION 13.6 • n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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Diastolic Blood Pressure
|
77.7 millimeter of mercury (mmHg)
STANDARD_DEVIATION 9.4 • n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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Heart Rate
|
75.1 beats per minute (beats/min)
STANDARD_DEVIATION 10.1 • n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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Body Temperature
|
36.37 celsius
STANDARD_DEVIATION 0.38 • n=560 Participants • SAF included all participants who received at least 1 injection of study drug.
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PRIMARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
National eye institute 25-item visual function questionnaire (NEI VFQ-25) is a condition-specific measure which was designed to capture the specific impact of vision loss on health-related quality of life (HRQoL). The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the "NEI VFQ-25 Scoring Algorithm - August 2000". The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.
Outcome measures
| Measure |
Aflibercept
n=553 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
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|---|---|
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Change From Baseline to Week 52 in NEI VFQ-25 Total Score
|
6.106 score on a scale
Interval 5.303 to 6.909
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
NEI VFQ-25 is a condition-specific measure which was designed to capture the specific impact of vision loss on HRQoL. The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the "NEI VFQ-25 Scoring Algorithm - August 2000". Items within each sub-scale are averaged together to create the 12 sub-scale Scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Sub-scales with at least one item answered can be used to generate a sub-scale score. Hence, scores represent the average for all items in the subscale that the respondent answered.The NEI VFQ-25 near activities subscale was scored from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
Outcome measures
| Measure |
Aflibercept
n=553 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
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|---|---|
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Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale
|
11.370 score on a scale
Interval 10.108 to 12.632
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SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
NEI VFQ-25 is a condition-specific measure which was designed to capture the specific impact of vision loss on HRQoL. The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the "NEI VFQ-25 Scoring Algorithm - August 2000". Items within each sub-scale are averaged together to create the 12 sub-scale Scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Sub-scales with at least one item answered can be used to generate a sub-scale score. Hence, scores represent the average for all items in the subscale that the respondent answered. The NEI VFQ-25 distant activities subscale was scored from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. Distant activities are defined as activities requiring distance vision, such as recognizing faces or reading street signs.
Outcome measures
| Measure |
Aflibercept
n=553 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
|
|---|---|
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Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale
|
7.331 score on a scale
Interval 6.118 to 8.545
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SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.
Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group 1985) starting at 4 meters. The values might range from 0 to 100. A higher score represents better functioning.
Outcome measures
| Measure |
Aflibercept
n=553 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
|
|---|---|
|
Change From Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score])
|
10.0 score on a scale
Interval 9.5 to 10.6
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire. Participants who were evaluable for this measure at given time point for the arm were included in the category.
Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT). For all visits where the OCT procedure was scheduled, images were captured and read by the investigator. All OCTs were electronically archived at the study sites as part of the source documentation.
Outcome measures
| Measure |
Aflibercept
n=553 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
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|---|---|
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Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT)
|
-175.38 microns
Interval -184.93 to -165.82
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SECONDARY outcome
Timeframe: Baseline, Week 52Population: Subjects in the FAS with gradable baseline and Week 52 FP and a DRSS of less than (\<) 61 at baseline. Participants who were evaluable for this measure at given time point for the arm were included in the category.
The ETDRS DRSS was assessed by FP according to the following scale for both eyes. The following severities are possible. 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
n=553 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
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|---|---|
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Proportion of Participants Progressing to Greater or Equal to (>=) 61 on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) as Assessed by Fundus Photography (FP)
|
0.4 proportion of participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52Population: SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time points for the arm were included in the categories.
Intraocular pressure (IOP) was measured using applanation tonometry Goldmann, Tonopen or approved alternative). The same method of intraocular pressure measurement was used in each participant throughout the study. For the measurement of intraocular pressure, a local anesthetic combined with fluorescein was applied topically to the eye being tested (example: one drop of oxybuprocain plus fluorescein). In the below table, pre-injection intraocular pressure for study eye was reported.
Outcome measures
| Measure |
Aflibercept
n=560 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
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|---|---|
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Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks
Change at Week 8
|
-0.3 millimeter of mercury (mmHg)
Standard Deviation 2.9
|
|
Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks
Change at Week 12
|
-0.5 millimeter of mercury (mmHg)
Standard Deviation 2.9
|
|
Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks
Change at Week 16
|
-0.3 millimeter of mercury (mmHg)
Standard Deviation 2.9
|
|
Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks
Change at Week 32
|
-0.1 millimeter of mercury (mmHg)
Standard Deviation 3.0
|
|
Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks
Change at Week 40
|
0.0 millimeter of mercury (mmHg)
Standard Deviation 3.0
|
|
Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks
Change at Week 4
|
-0.4 millimeter of mercury (mmHg)
Standard Deviation 2.9
|
|
Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks
Change at Week 24
|
-0.2 millimeter of mercury (mmHg)
Standard Deviation 3.0
|
|
Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks
Change at Week 48
|
0.0 millimeter of mercury (mmHg)
Standard Deviation 3.0
|
|
Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks
Change at Week 52
|
0.1 millimeter of mercury (mmHg)
Standard Deviation 3.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.
Systolic blood pressure was measured in a consistent and standardized way according to locally established practice.
Outcome measures
| Measure |
Aflibercept
n=560 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 52
|
-0.1 millimeter of mercury (mmHg)
Standard Deviation 15.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.
Diastolic blood pressure was measured in a consistent and standardized way according to locally established practice.
Outcome measures
| Measure |
Aflibercept
n=560 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
|
|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 52
|
-0.3 millimeter of mercury (mmHg)
Standard Deviation 9.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.
Heart rate was measured in a consistent and standardized way according to locally established practice.
Outcome measures
| Measure |
Aflibercept
n=560 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
|
|---|---|
|
Change From Baseline in Heart Rate at Week 52
|
-1.0 beats per minute (beats/min)
Standard Deviation 9.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.
Temperature was measured in a consistent and standardized way according to locally established practice.
Outcome measures
| Measure |
Aflibercept
n=560 Participants
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
|
|---|---|
|
Change From Baseline in Body Temperature at Week 52
|
-0.04 celsius
Standard Deviation 0.41
|
Adverse Events
Aflibercept
Serious adverse events
| Measure |
Aflibercept
n=560 participants at risk
Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
|
|---|---|
|
Cardiac disorders
Atrioventricular block
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Cardiac disorders
Bundle branch block right
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Cardiac disorders
Cardiac failure
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Cardiac disorders
Cardiac failure acute
|
0.36%
2/560 • Number of events 3 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Cardiac disorders
Cardiac failure chronic
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Cardiac disorders
Cardiac failure congestive
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Cardiac disorders
Mitral valve incompetence
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Eye disorders
Anterior chamber inflammation
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Eye disorders
Cataract subcapsular
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Eye disorders
Posterior capsule opacification
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Eye disorders
Vitreous haemorrhage
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Eye disorders
Vitritis
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Anal abscess
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Boutonneuse fever
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Cellulitis
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Diabetic foot infection
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Endophthalmitis
|
0.54%
3/560 • Number of events 3 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Erysipelas
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Osteomyelitis
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Parotitis
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Pneumonia
|
1.1%
6/560 • Number of events 6 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Pyelonephritis chronic
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Infections and infestations
Septic shock
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Injury, poisoning and procedural complications
Fracture
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Investigations
Echocardiogram abnormal
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Investigations
Influenza A virus test positive
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Nervous system disorders
Cerebrovascular accident
|
0.54%
3/560 • Number of events 3 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Nervous system disorders
Lacunar stroke
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Nervous system disorders
Vascular encephalopathy
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Psychiatric disorders
Depression
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Psychiatric disorders
Major depression
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Psychiatric disorders
Suicide attempt
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Reproductive system and breast disorders
Prostatitis
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Surgical and medical procedures
Vitrectomy
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Vascular disorders
Arteriosclerosis
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Vascular disorders
Hypertensive crisis
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.36%
2/560 • Number of events 2 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
|
Vascular disorders
Peripheral vascular disorder
|
0.18%
1/560 • Number of events 1 • From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Center provides publication/presentation related to the Study Drug/Results 60 days prior to due date submission/presentation allowing Bayer review. Center receives notification within 45 days, Center reminds Bayer of Publication´s due date. Expected comments are within 60 days, if not Center to publish. Multi-center´s Results publication coordinates through Bayer Center publishes their Results provided overall results haven't been published within 18 months from Study completion for compliance.
- Publication restrictions are in place
Restriction type: OTHER