Study of the Effects of High Dose Aflibercept Injected In... | NCT04423718 | Trialant
NCT04423718
Sponsor
Bayer
Status
Completed
Last Update Posted
Aug 29, 2025Actual
Enrollment
1,011Actual
Phase
Phase 3
Conditions
Neovascular Age-Related Macular Degeneration
Interventions
Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
Countries
United States
Argentina
Australia
Austria
Bulgaria
Canada
China
Czechia
Estonia
France
Georgia
Hungary
Israel
Italy
Japan
Latvia
Lithuania
Portugal
Russia
Serbia
Singapore
Slovakia
South Korea
Spain
Switzerland
Taiwan
Ukraine
Protocol Section
Identification Module
NCT ID
NCT04423718
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
20968
Secondary IDs
ID
Type
Description
Link
2019-003851-12
EudraCT Number
Brief Title
Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye
Official Title
Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Acronym
PULSAR
Organization
BayerINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 11, 2020Actual
Primary Completion Date
Jul 27, 2022Actual
Completion Date
Aug 7, 2024Actual
First Submitted Date
Jun 8, 2020
First Submission Date that Met QC Criteria
Jun 8, 2020
First Posted Date
Jun 9, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jul 9, 2023
Results First Submitted that Met QC Criteria
Aug 11, 2023
Results First Posted Date
Sep 6, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 6, 2025
Last Update Posted Date
Aug 29, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BayerINDUSTRY
Collaborators
Name
Class
Regeneron Pharmaceuticals
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.
Detailed Description
Not provided
Conditions Module
Conditions
Neovascular Age-Related Macular Degeneration
Keywords
nAMD
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,011Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Aflibercept 2q8
Active Comparator
In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental)
Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Aflibercept HDq16
Experimental
Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Drug
Solution in Vial, intravitreal (IVT) injection
Aflibercept 2q8
Aflibercept HDq12
Aflibercept HDq16
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
At baseline and Week 48
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
At baseline and Week 60
Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
Decrease in BCVA determined to be primarily the result of nAMD in the study eye.
Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
Other protocol-specified inclusion criteria.
Additional inclusion criteria for Year 3:
At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92).
Participant is enrolled at a site that participates in the extension period.
Exclusion Criteria:
Causes of CNV other than nAMD in the study eye.
Scar, fibrosis, or atrophy involving the central subfield in the study eye.
Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.
Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
History of idiopathic or autoimmune uveitis in the study eye.
Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.
Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg).
Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.
Other protocol-specified exclusion criteria
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Arizona Retina & Vitreous Consultants - Central Phoenix Phoenix
Sun X, Dai H, Chen Y, Sun X, Tao L, Xiao J, Han M, Zhao M, Wang L, Schulze A, Schmidt-Ott UM, Zhao M, Zhang X, Wang Z, Leal S, Wei W; PULSAR investigators. Intravitreal aflibercept 8 mg in patients with neovascular age-related macular degeneration from China: 48-week results from the PULSAR trial. Int J Retina Vitreous. 2026 Jun 26. doi: 10.1186/s40942-026-00876-5. Online ahead of print.
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Overall, 1395 participants were screened, of whom 383 participants did not complete screening, 1 participant was randomized in error although he/she did not complete screening and had withdrawn consent. A total of 1011 participants were randomized in nearly equal numbers to 1 of the 3 treatment groups.
Recruitment Details
The study was conducted at 251 centers in 27 countries/regions with first participant first visit on 20-AUG-2020 and last participant last visit (Week 156) on 07-Aug-2024.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Aflibercept 2q8 (Week 0-96) / HD (up to Week 156)
Participants enrolled in main study received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals up to 96 weeks. Participants enrolled in the extension originally assigned to 2q8 in main study and switched to high dose aflibercept starting at Week 96.
Periods
Title
Milestones
Reasons Not Completed
Main Study
Type
Comment
Milestone Data
STARTED
Treated
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 27, 2023
Jul 9, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Belgium
Colombia
Denmark
Germany
Hong Kong
Netherlands
Turkey (Türkiye)
United Kingdom
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Up to Week 108: Participant and Investigator masked. Week 108 to Week 156: Participant and Investigator unmasked to treatment intervals.
Loewenstein A, Schmidt-Ott U, Do DV, Lanzetta P, Leal S, Berliner AJ, Chu KW, Barakat MR, Ghorayeb G, Stewart MW, Spitzer MS, Zhang X, McCullough A, Tueckmantel C, Avila D, Morgan-Warren P, Brunck L, Dupljak A, Hymowitz M, Portnoy A, Gale R. Intraocular Pressure Outcomes with Intravitreal Aflibercept 8 mg: A 96-Week Pooled Analysis from PULSAR and PHOTON. Ophthalmol Ther. 2026 Jun 13. doi: 10.1007/s40123-026-01424-y. Online ahead of print.
Chang A, Sun X, Iida T, Lai TYY, Wong TY, Cheung CMG, Lee WK, Zhang X, Schulze A, Schmidt-Ott UM, Zhao M, Hasanbasic Z, Leal S, Chen SJ; PULSAR study investigators. Intravitreal aflibercept 8 mg versus 2 mg in Asian patients with neovascular age-related macular degeneration: 48-week analysis of the Phase 3 PULSAR trial. Asia Pac J Ophthalmol (Phila). 2026 Jan-Feb;15(1):100278. doi: 10.1016/j.apjo.2026.100278. Epub 2026 Jan 8.
Lee WK, Wong TY, Chen SJ, Sun X, Cheung CMG, Silva R, Ricci F, Zhang X, Machewitz T, Schulze A, Schmidt-Ott UM, Zhao M, Hasanbasic Z, Leal S, Iida T; PULSAR Study Investigators. Aflibercept 8 mg in Polypoidal Choroidal Vasculopathy: Post Hoc Analysis of the PULSAR Randomized Clinical Trial. JAMA Ophthalmol. 2026 Feb 1;144(2):129-137. doi: 10.1001/jamaophthalmol.2025.5098.
Lanzetta P, Korobelnik JF, Heier JS, Leal S, Holz FG, Clark WL, Eichenbaum D, Iida T, Xiaodong S, Berliner AJ, Schulze A, Schmelter T, Schmidt-Ott U, Zhang X, Vitti R, Chu KW, Reed K, Rao R, Bhore R, Cheng Y, Sun W, Hirshberg B, Yancopoulos GD, Wong TY; PULSAR Investigators. Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial. Lancet. 2024 Mar 23;403(10432):1141-1152. doi: 10.1016/S0140-6736(24)00063-1. Epub 2024 Mar 7.
FG001
Aflibercep HDq12 (Week 0-156)
Participants enrolled in main study received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants enrolled in the extension continued with HD aflibercept at their latest dosing interval at Week 96.
FG002
Aflibercept HDq16 (Week 0-156)
Participants enrolled in main study received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants enrolled in the extension continued with HD aflibercept at their latest dosing interval at Week 96.
FG000336 subjects
FG001335 subjects
FG002338 subjects
COMPLETED
Completed study treatment until Week 96
FG000286 subjects
FG001291 subjects
FG002292 subjects
NOT COMPLETED
FG00050 subjects
FG00144 subjects
FG00246 subjects
Type
Comment
Reasons
Adverse Event
FG0009 subjects
FG0015 subjects
FG0028 subjects
Physician Decision
FG0003 subjects
FG0013 subjects
FG0022 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
Lost to Follow-up
FG0003 subjects
FG0013 subjects
FG0024 subjects
Lack of Efficacy
FG0002 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG00014 subjects
FG00120 subjects
FG00220 subjects
Death
FG00010 subjects
FG0017 subjects
FG0027 subjects
COVID-19 pandemic
FG0002 subjects
FG0012 subjects
FG0022 subjects
Other
FG0007 subjects
FG0013 subjects
FG0022 subjects
Extension Phase
Type
Comment
Milestone Data
STARTED
Enrolled in extension
FG000208 subjects
FG001210 subjects
FG002207 subjects
Treated
FG000208 subjects
FG001210 subjects
FG002207 subjects
COMPLETED
Completed study treatment through Week 156
FG000187 subjects
FG001186 subjects
FG002191 subjects
NOT COMPLETED
FG00021 subjects
FG00124 subjects
FG00216 subjects
Type
Comment
Reasons
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
Logistical problems
FG000
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
BG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
BG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000336
BG001335
BG002338
BG0031009
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG000336
ParticipantsBG001335
ParticipantsBG002338
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000336
ParticipantsBG001335
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000336
ParticipantsBG001335
ParticipantsBG002
Baseline BCVA measured by the ETDRS letter score
Visual function of the study eye was assessed at a distance of 4 meters using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
Mean
Standard Deviation
scores on a scale
Title
Denominators
Categories
ParticipantsBG000336
ParticipantsBG001335
ParticipantsBG002
Baseline choroidal neovascularization (CNV) size
Full analysis set, except 1 participant who did not have a valid baseline measure.
Mean
Standard Deviation
mm²
Title
Denominators
Categories
ParticipantsBG000336
ParticipantsBG001335
ParticipantsBG002
Baseline total lesion area
Full analysis set, except 2 participants who did not have a valid baseline measure.
Mean
Standard Deviation
mm²
Title
Denominators
Categories
ParticipantsBG000336
ParticipantsBG001335
ParticipantsBG002
Baseline central subfield retinal thickness (CST)
Full analysis set, except 3 participants who did not have a valid baseline measure.
Mean
Standard Deviation
µm
Title
Denominators
Categories
ParticipantsBG000335
ParticipantsBG001335
ParticipantsBG002
Baseline NEI-VFQ-25 total score
NEI-VFQ-25 = National Eye Institute Visual Functioning Questionnaire-25
NEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems)
Full analysis set, with the participants who completed the NEI-VFQ-25 at baseline.
Mean
Standard Deviation
scores on a scale
Title
Denominators
Categories
ParticipantsBG000317
ParticipantsBG001321
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. Estimand mainly based on hypothetical strategy.
Posted
Least Squares Mean
Standard Error
scores on a scale
At baseline and Week 48
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Units
Counts
Participants
OG000336
OG001335
OG002338
Title
Denominators
Categories
Title
Measurements
OG0007.03± 0.74
OG0016.06± 0.77
OG0025.89± 0.72
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
HDq12 - 2q8
Mixed Models Analysis
Adjusted for baseline BCVA and randomization strata
0.0009
Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with next primary endpoint (HDq16-2q8) / within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq12-2q8)
Difference in LS means
-0.97
2-Sided
95
-2.87
0.92
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Secondary
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. Estimand mainly based on hypothetical strategy.
Posted
Least Squares Mean
Standard Error
scores on a scale
At baseline and Week 60
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Secondary
Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. Estimand mainly based on hypothetical strategy.
The Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to missing assessment at the respective visit. These participants with missing assessments were not included in the analysis.
Posted
Number
Percentage of participants
At Week 16
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Secondary
Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.
The Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to 1 participant per each treatment group with no post-baseline BCVA. These participants with missing assessments were not included in the analysis.
Posted
Number
Percentage of participants
At baseline and Week 48
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Secondary
Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 48
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.
The Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to 1 participant per each treatment group with no post-baseline BCVA. These participants with missing assessments were not included in the analysis.
Posted
Number
Percentage of participants
At Week 48
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Secondary
Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.
Posted
Least Squares Mean
Standard Error
mm^2
At baseline and Week 48
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Secondary
Change in Total Lesion Area From Baseline to Week 48
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.
Posted
Least Squares Mean
Standard Error
mm^2
At baseline and Week 48
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Secondary
Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Week 48
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.
The Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to missing assessments at the respective visit. These participants with missing assessments were not included in the analysis.
Posted
Number
Percentage of participants
At Week 48
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Secondary
Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.
Posted
Least Squares Mean
Standard Error
µm
At baseline and Week 48
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Secondary
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48
NEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems)
Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.
Posted
Least Squares Mean
Standard Error
scores on a scale
At baseline and Week 48
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Secondary
Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Week 48
Pharmacokinetic analysis set: included all participants who received any study treatment and who had at least 1 non-missing drug concentration measurement following the first dose of study treatment
Posted
Geometric Mean
Geometric Coefficient of Variation
mg/L
Up to Week 48
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
Secondary
Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response
Posted
Count of Participants
Participants
Up to week 96
ID
Title
Description
OG000
Aflibercept 2q8
Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.
OG001
Aflibercept HDq12
Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria
OG002
Aflibercept HDq16
Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria
OG003
All Aflibercept HD
All participants from aflibercept HDq12 (Week 0-96) and aflibercept HDq16 (Week 0-96).
Time Frame
Through Week 96, from first dosing up to 30 days after last dosing (active or sham procedure). Through Week 156, from first dosing up to 30 days after last dosing (active or sham procedure) or the Week 156 visit, whichever was later. AE reporting for all-cause mortality considers all deaths occurred at any time during the study before the last contact.
Description
Ocular TEAEs in study eye and non-ocular TEAEs (ocular TEAEs in fellow eye are excluded)
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Aflibercept 2q8 (Week 0- 96)
Participants enrolled in main study received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals.
12
336
69
336
179
336
EG001
Aflibercept HDq12 (Week 0- 96)
Participants enrolled in main study received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals. Participants in this group could have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria.
11
335
83
335
163
335
EG002
Aflibercept HDq16 (Week 0- 96)
Participants enrolled in main study received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals. Participants in this group could have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria.
7
338
72
338
180
338
EG003
All Aflibercept HD (Week 0- 96)
All participants from aflibercept HDq12 (Week 0-96) and aflibercept HDq16 (Week 0-96).
18
673
155
673
343
673
EG004
Aflibercept 2q8/HD (Week 0- 156)
Participants enrolled in the extension originally assigned to 2q8 in main study and switched to high dose aflibercept every 12 weeks starting at Week 96. Participants in this group could have their treatment intervals adjusted in the extension according to pre-specified dose regimen modification (E-DRM) criteria.
4
208
49
208
136
208
EG005
Aflibercept HDq12 (Week 0- 156)
Participants enrolled in the extension originally assigned to HDq12 in main study and continued with HD aflibercept at their latest dosing interval at Week 96. Participants in this group could have their treatment intervals adjusted in the extension according to pre-specified dose regimen modification (E-DRM) criteria.
7
210
61
210
120
210
EG006
Aflibercept HDq16 (Week 0- 156)
Participants enrolled in the extension originally assigned to HDq16 in main study and continued with HD aflibercept at their latest dosing interval at Week 96. Participants in this group could have their treatment intervals adjusted in the extension according to pre-specified dose regimen modification (E-DRM) criteria.
2
207
61
207
135
207
EG007
All Aflibercept HD (Week 0- 156)
All participants from aflibercept HDq12 (Week 0-156) and aflibercept HDq16 (Week 0-156). Participants in this group could have their treatment intervals adjusted in the extension according to pre-specified dose regimen modification (E-DRM) criteria.
9
417
122
417
255
417
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG0031 events1 affected673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Hypochromic anaemia
Blood and lymphatic system disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0002 events2 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0024 events4 affected338 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events2 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0003 events1 affected336 at risk
EG0012 events2 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0011 events1 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0013 events3 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events2 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events2 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Hypertensive heart disease
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0011 events1 affected335 at risk
EG0023 events3 affected338 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Goitre
Endocrine disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Angle closure glaucoma
Eye disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Cataract
Eye disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events2 affected335 at risk
EG0022 events2 affected338 at risk
EG003
Dry age-related macular degeneration
Eye disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Macular detachment
Eye disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Retinal detachment
Eye disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0012 events2 affected335 at risk
EG0023 events3 affected338 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0006 events1 affected336 at risk
EG0012 events2 affected335 at risk
EG0022 events2 affected338 at risk
EG003
Retinal tear
Eye disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Abdominal strangulated hernia
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events2 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Haemoperitoneum
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events2 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0011 events1 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Mesenteric artery thrombosis
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Pancreatitis chronic
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Asthenia
General disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Chest pain
General disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events2 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Cyst
General disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Death
General disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0022 events2 affected338 at risk
EG003
Oedema
General disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Pain
General disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Peripheral swelling
General disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0002 events2 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Haemorrhagic cholecystitis
Hepatobiliary disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Haemorrhagic hepatic cyst
Hepatobiliary disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Hepatic vascular thrombosis
Hepatobiliary disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0022 events2 affected338 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0022 events2 affected338 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events2 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Endophthalmitis
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Gangrene
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Liver abscess
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Otitis externa
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0002 events2 affected336 at risk
EG0015 events5 affected335 at risk
EG0025 events5 affected338 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0022 events1 affected338 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0023 events2 affected338 at risk
EG003
Q fever
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Sepsis
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Systemic infection
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0005 events5 affected336 at risk
EG0011 events1 affected335 at risk
EG0022 events2 affected338 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Craniofacial fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0002 events2 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Periprosthetic fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0002 events2 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Shoulder fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0022 events2 affected338 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events2 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0002 events2 affected336 at risk
EG0010 events0 affected335 at risk
EG0022 events2 affected338 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0011 events1 affected335 at risk
EG0022 events1 affected338 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0002 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0003 events3 affected336 at risk
EG0015 events5 affected335 at risk
EG0024 events3 affected338 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Rotator cuff tear arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Vertebral foraminal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Adenocarcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0012 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0003 events3 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Bone neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Breast cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Colon neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0011 events1 affected335 at risk
EG0022 events2 affected338 at risk
EG003
Head and neck cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Hypopharyngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Lung carcinoma cell type unspecified stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Malignant peritoneal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Non-small cell lung cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Oesophageal carcinoma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Penile squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0000 events0 affected336 at risk
EG0010 events0 affected335 at risk
EG0021 events1 affected338 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0/27.0)
Systematic Assessment
EG0001 events1 affected336 at risk
EG0011 events1 affected335 at risk
EG0020 events0 affected338 at risk
EG003
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin
OG000
OG002
HDq16 - 2q8
Mixed Models Analysis
Adjusted for baseline BCVA and randomization strata
0.0011
Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with secondary endpoint (no IRF no SRF at W16)/within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq16-2q8)
Difference in LS means
-1.14
2-Sided
95
-2.97
0.69
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Non-Inferiority
One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin
Units
Counts
Participants
OG000336
OG001335
OG002338
Title
Denominators
Categories
Title
Measurements
OG0007.23± 0.68
OG0016.37± 0.74
OG0026.31± 0.66
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
HDq12 - 2q8
Mixed Models Analysis
Adjusted for baseline BCVA and randomization strata
0.0002
EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested for EMA/PMDA after primary endpoint (HDq12-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with next primary endpoint (HDq16-2q8)
Difference in LS means
-0.86
2-Sided
95
-2.57
0.84
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Non-Inferiority
One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin
OG000
OG002
HDq16 - 2q8
Mixed Models Analysis
Adjusted for baseline BCVA and randomization strata
<0.0001
EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested after primary endpoint (HDq16-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with secondary endpoint test (no IRF no SRF at W16)
Difference in LS means
-0.92
2-Sided
95
-2.51
0.66
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Non-Inferiority
One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin
OG003
All Aflibercept HD
Included all participants from aflibercept HDq12 and aflibercept HDq16
Units
Counts
Participants
OG000335
OG001333
OG002334
OG003667
Title
Denominators
Categories
Title
Measurements
OG00051.6
OG00161.6
OG00265.0
OG00363.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
All HD - 2q8
Cochran-Mantel-Haenszel
CMH test stratified by baseline BCVA and randomization strata
0.0002
Strictly hierarchical testing procedure to adjust for multiplicity.
Difference
11.733
2-Sided
95
5.263
18.204
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach
Superiority
One sided test (alpha = 0.025) for superiority
Units
Counts
Participants
OG000335
OG001334
OG002337
Title
Denominators
Categories
Title
Measurements
OG00022.1
OG00120.7
OG00221.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
HDq12 - 2q8
Cochran-Mantel-Haenszel
CMH test stratified by baseline BCVA and randomization strata
0.5704
Nominal p-value, not adjusted for multiplicity
Difference
-1.748
2-Sided
95
-7.784
4.287
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach
Equivalence
Two sided test (alpha = 0.05)
OG000
OG002
HDq16 - 2q8
Cochran-Mantel-Haenszel
CMH test stratified by baseline BCVA and randomization strata
0.7611
Nominal p-value, not adjusted for multiplicity
Difference
-0.939
2-Sided
95
-6.997
5.119
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach
Equivalence
Two sided test (alpha = 0.05)
Units
Counts
Participants
OG000335
OG001334
OG002337
Title
Denominators
Categories
Title
Measurements
OG00057.9
OG00156.9
OG00254.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
HDq12 - 2q8
Cochran-Mantel-Haenszel
CMH test stratified by baseline BCVA and randomization strata
0.9554
Nominal p-value, not adjusted for multiplicity
Difference
-0.182
2-Sided
95
-6.565
6.200
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach
Equivalence
Two sided test (alpha = 0.05)
OG000
OG002
HDq16 - 2q8
Cochran-Mantel-Haenszel
CMH test stratified by baseline BCVA and randomization strata
0.4834
Nominal p-value, not adjusted for multiplicity
Difference
-2.221
2-Sided
95
-8.435
3.994
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach
Equivalence
Two sided test (alpha = 0.05)
Units
Counts
Participants
OG000336
OG001335
OG002338
Title
Denominators
Categories
Title
Measurements
OG000-2.43± 0.31
OG001-3.65± 0.28
OG002-2.91± 0.29
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
HDq12 - 2q8
Mixed Models Analysis
Adjusted for baseline CNV size and randomization strata
0.0009
Nominal p-value, not adjusted for multiplicity
Difference in LS means
-1.22
2-Sided
95
-1.94
-0.51
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Equivalence
Two sided test (alpha = 0.05)
OG000
OG002
HDq16 - 2q8
Mixed Models Analysis
Adjusted for baseline CNV size and randomization strata
0.2076
Nominal p-value, not adjusted for multiplicity
Difference in LS means
-0.48
2-Sided
95
-1.22
0.27
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Equivalence
Two sided test (alpha = 0.05)
Units
Counts
Participants
OG000336
OG001335
OG002338
Title
Denominators
Categories
Title
Measurements
OG0000.09± 0.22
OG001-0.46± 0.19
OG002-0.35± 0.20
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
HDq12 - 2q8
Mixed Models Analysis
Adjusted for baseline total lesion area and randomization strata
0.0287
Nominal p-value, not adjusted for multiplicity
Difference in LS means
-0.55
2-Sided
95
-1.04
-0.06
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Equivalence
Two sided test (alpha = 0.05)
OG000
OG002
HDq16 - 2q8
Mixed Models Analysis
Adjusted for baseline total lesion area and randomization strata
0.0870
Nominal p-value, not adjusted for multiplicity
Difference in LS means
-0.44
2-Sided
95
-0.94
0.06
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Equivalence
Two sided test (alpha = 0.05)
Units
Counts
Participants
OG000335
OG001332
OG002334
Title
Denominators
Categories
Title
Measurements
OG00059.4
OG00171.1
OG00266.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
HDq12 - 2q8
Cochran-Mantel-Haenszel
CMH test stratified by baseline BCVA and randomization strata
0.0015
Nominal p-value, not adjusted for multiplicity
Difference
11.725
2-Sided
95
4.527
18.923
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach
Equivalence
Two sided test (alpha = 0.05)
OG000
OG002
HDq16 - 2q8
Cochran-Mantel-Haenszel
CMH test stratified by baseline BCVA and randomization strata
0.0458
Nominal p-value, not adjusted for multiplicity
Difference
7.451
2-Sided
95
0.142
14.760
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach
Equivalence
Two sided test (alpha = 0.05)
Units
Counts
Participants
OG000336
OG001335
OG002338
Title
Denominators
Categories
Title
Measurements
OG000-136.25± 4.24
OG001-147.37± 4.01
OG002-146.76± 3.76
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
HDq12 - 2q8
Mixed Models Analysis
Adjusted for baseline CST and randomization strata
0.0283
Nominal p-value, not adjusted for multiplicity
Difference in LS means
-11.12
2-Sided
95
-21.06
-1.18
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Equivalence
Two sided test (alpha = 0.05)
OG000
OG002
HDq16 - 2q8
Mixed Models Analysis
Adjusted for baseline CST and randomization strata
0.0321
Nominal p-value, not adjusted for multiplicity
Difference in LS means
-10.51
2-Sided
95
-20.12
-0.90
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Equivalence
Two sided test (alpha = 0.05)
Units
Counts
Participants
OG000336
OG001335
OG002338
Title
Denominators
Categories
Title
Measurements
OG0004.22± 0.70
OG0013.50± 0.70
OG0023.35± 0.72
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
HDq12 - 2q8
Mixed Models Analysis
Adjusted for baseline NEI-VFQ-25 total score and randomization strata
0.3817
Nominal p-value, not adjusted for multiplicity
Difference in LS means
-0.72
2-Sided
95
-2.35
0.90
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Equivalence
Two sided test (alpha = 0.05)
OG000
OG002
HDq16 - 2q8
Mixed Models Analysis
Adjusted for baseline NEI-VFQ-25 total score and randomization strata
0.3070
Nominal p-value, not adjusted for multiplicity
Difference in LS means
-0.87
2-Sided
95
-2.55
0.80
Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM
Equivalence
Two sided test (alpha = 0.05)
Units
Counts
Participants
OG000308
OG001313
OG002313
Title
Denominators
Categories
Week 4
ParticipantsOG000287
ParticipantsOG001295
ParticipantsOG002299
Title
Measurements
OG000NA± NANot calculated (less than 2/3 of values per timepoint are \>= Lower level of quantification (LLOQ) for geometric mean calculation).
OG001NA± NANot calculated (less than 2/3 of values per timepoint are \>= Lower level of quantification (LLOQ) for geometric mean calculation).
OG002NA± NANot calculated (less than 2/3 of values per timepoint are \>= Lower level of quantification (LLOQ) for geometric mean calculation).
Visit 5: within 3 to 7 days after the Week 8
ParticipantsOG000263
ParticipantsOG001269
ParticipantsOG002255
Title
Measurements
OG000
Week 12
ParticipantsOG000292
ParticipantsOG001291
ParticipantsOG002302
Title
Measurements
OG000
Week 28
ParticipantsOG000268
ParticipantsOG001291
ParticipantsOG002283
Title
Measurements
OG000
Week 48
ParticipantsOG000265
ParticipantsOG001275
ParticipantsOG002273
Title
Measurements
OG000
Units
Counts
Participants
OG000284
OG001295
OG002295
OG003590
Title
Denominators
Categories
Treatment-emergent positive or Treatment-boosted, maximum ADA titers - Low (< 1000)
Title
Measurements
OG0008
OG00114
OG00213
OG00327
Treatment-emergent positive or Treatment-boosted, maximum ADA titers - Moderate (1000-10000)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Treatment-emergent positive or Treatment-boosted, maximum ADA titers - High (> 10000)
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0041 events1 affected208 at risk
EG0051 events1 affected210 at risk
EG0061 events1 affected207 at risk
EG0072 events2 affected417 at risk
4 events
4 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
3 events
3 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0061 events1 affected207 at risk
EG0072 events2 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0061 events1 affected207 at risk
EG0072 events2 affected417 at risk
1 events
1 affected
673 at risk
EG0041 events1 affected208 at risk
EG0051 events1 affected210 at risk
EG0061 events1 affected207 at risk
EG0072 events2 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
2 events
2 affected
673 at risk
EG0044 events2 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
2 events
2 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
3 events
3 affected
673 at risk
EG0041 events1 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
3 events
3 affected
673 at risk
EG0041 events1 affected208 at risk
EG0051 events1 affected210 at risk
EG0063 events3 affected207 at risk
EG0074 events4 affected417 at risk
2 events
2 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
4 events
4 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0062 events2 affected207 at risk
EG0072 events2 affected417 at risk
1 events
1 affected
673 at risk
EG0041 events1 affected208 at risk
EG0051 events1 affected210 at risk
EG0061 events1 affected207 at risk
EG0072 events2 affected417 at risk
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
4 events
4 affected
673 at risk
EG0042 events2 affected208 at risk
EG0053 events3 affected210 at risk
EG0065 events5 affected207 at risk
EG0078 events8 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
5 events
5 affected
673 at risk
EG0041 events1 affected208 at risk
EG0052 events2 affected210 at risk
EG0062 events2 affected207 at risk
EG0074 events4 affected417 at risk
4 events
4 affected
673 at risk
EG0046 events1 affected208 at risk
EG0051 events1 affected210 at risk
EG0062 events2 affected207 at risk
EG0073 events3 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0061 events1 affected207 at risk
EG0072 events2 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
2 events
2 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
2 events
2 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
2 events
2 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
2 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0052 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0072 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
3 events
3 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
3 events
3 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
2 events
2 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0061 events1 affected207 at risk
EG0072 events2 affected417 at risk
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
0 events
0 affected
673 at risk
EG0040 events0 affected208 at risk
EG0051 events1 affected210 at risk
EG0060 events0 affected207 at risk
EG0071 events1 affected417 at risk
2 events
2 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0061 events1 affected207 at risk
EG0071 events1 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
2 events
2 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0063 events3 affected207 at risk
EG0073 events3 affected417 at risk
2 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
2 events
2 affected
673 at risk
EG0040 events0 affected208 at risk
EG0052 events2 affected210 at risk
EG0060 events0 affected207 at risk
EG0072 events2 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
0 events
0 affected
673 at risk
EG0041 events1 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected210 at risk
EG0060 events0 affected207 at risk
EG0070 events0 affected417 at risk
1 events
1 affected
673 at risk
EG0040 events0 affected208 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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10 events
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673 at risk
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0 events
0 affected
673 at risk
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0 affected
673 at risk
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1 events
1 affected
673 at risk
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2 events
1 affected
673 at risk
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3 events
2 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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0 events
0 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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3 events
3 affected
673 at risk
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0 events
0 affected
673 at risk
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0 affected
673 at risk
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0 affected
673 at risk
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0 events
0 affected
673 at risk
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0 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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0 events
0 affected
673 at risk
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0 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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1 events
1 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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1 events
1 affected
673 at risk
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0 events
0 affected
673 at risk
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2 events
2 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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1 events
1 affected
673 at risk
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2 events
2 affected
673 at risk
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1 events
1 affected
673 at risk
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0 events
0 affected
673 at risk
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2 events
2 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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3 events
2 affected
673 at risk
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1 events
1 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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1 events
1 affected
673 at risk
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0 events
0 affected
673 at risk
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0 affected
673 at risk
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0 events
0 affected
673 at risk
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9 events
8 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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2 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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0 events
0 affected
673 at risk
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0 events
0 affected
673 at risk
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1 events
1 affected
673 at risk
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3 events
3 affected
673 at risk
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1 events
1 affected
673 at risk
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0 affected
673 at risk
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1 events
1 affected
673 at risk
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1 events
1 affected
673 at risk
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0 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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1 events
1 affected
673 at risk
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1 affected
673 at risk
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0 affected
673 at risk
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1 affected
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0 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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0 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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673 at risk
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0 affected
673 at risk
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2 affected
673 at risk
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0 affected
673 at risk
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1 affected
673 at risk
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0 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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3 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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0 affected
673 at risk
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1 affected
673 at risk
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673 at risk
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673 at risk
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1 affected
673 at risk
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0 affected
673 at risk
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1 affected
673 at risk
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0 affected
673 at risk
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1 affected
673 at risk
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0 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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2 affected
673 at risk
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1 affected
673 at risk
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0 affected
673 at risk
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3 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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0 affected
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3 affected
673 at risk
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1 affected
673 at risk
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1 affected
673 at risk
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0 affected
673 at risk
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1 affected
673 at risk
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0 affected
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0 affected
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2 affected
673 at risk
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1 affected
673 at risk
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0 affected
673 at risk
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1 affected
673 at risk
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33 affected
673 at risk
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58 events
44 affected
673 at risk
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25 events
22 affected
673 at risk
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12 events
12 affected
673 at risk
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132 events
128 affected
673 at risk
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56 events
45 affected
673 at risk
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31 events
26 affected
673 at risk
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EG00511 events11 affected210 at risk
EG00620 events14 affected207 at risk
EG00731 events25 affected417 at risk
40 events
23 affected
673 at risk
EG00420 events8 affected208 at risk
EG00521 events12 affected210 at risk
EG00612 events8 affected207 at risk
EG00733 events20 affected417 at risk
25 events
23 affected
673 at risk
EG0049 events7 affected208 at risk
EG0057 events6 affected210 at risk
EG00615 events14 affected207 at risk
EG00722 events20 affected417 at risk
42 events
31 affected
673 at risk
EG00424 events14 affected208 at risk
EG00524 events11 affected210 at risk
EG00615 events14 affected207 at risk
EG00739 events25 affected417 at risk
22 events
21 affected
673 at risk
EG00422 events15 affected208 at risk
EG0056 events6 affected210 at risk
EG00616 events12 affected207 at risk
EG00722 events18 affected417 at risk
49 events
45 affected
673 at risk
EG00420 events18 affected208 at risk
EG00525 events21 affected210 at risk
EG00615 events15 affected207 at risk
EG00740 events36 affected417 at risk
0.03
± 70.29
OG0010.14± 78.69
OG0020.13± 82.50
NA
± NA
Not calculated (less than 2/3 of values per timepoint are \>= Lower level of quantification (LLOQ) for geometric mean calculation).
OG0010.02± 81.35
OG0020.02± 84.06
NA
± NA
Not calculated (less than 2/3 of values per timepoint are \>= Lower level of quantification (LLOQ) for geometric mean calculation).
OG001NA± NANot calculated (less than 2/3 of values per timepoint are \>= Lower level of quantification (LLOQ) for geometric mean calculation).
OG002NA± NANot calculated (less than 2/3 of values per timepoint are \>= Lower level of quantification (LLOQ) for geometric mean calculation).
NA
± NA
Not calculated (less than 2/3 of values per timepoint are \>= Lower level of quantification (LLOQ) for geometric mean calculation).
OG001NA± NANot calculated (less than 2/3 of values per timepoint are \>= Lower level of quantification (LLOQ) for geometric mean calculation).
OG002NA± NANot calculated (less than 2/3 of values per timepoint are \>= Lower level of quantification (LLOQ) for geometric mean calculation).