A Study of Ranibizumab Injection in Subjects With Clinica... | NCT00473382 | Trialant
NCT00473382
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Apr 17, 2017Actual
Enrollment
382Actual
Phase
Phase 3
Conditions
Diabetes Mellitus
Macular Edema
Interventions
Ranibizumab
Sham injection
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00473382
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
FVF4168g
Secondary IDs
Not provided
Brief Title
A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus (RIDE)
Official Title
A Phase III, Double-masked, Multicenter, Randomized, Sham Injection-controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus
Acronym
RIDE
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Mar 2017
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
Jun 2007
Primary Completion Date
Jan 2011Actual
Completion Date
Sep 2012Actual
First Submitted Date
May 13, 2007
First Submission Date that Met QC Criteria
May 13, 2007
First Posted Date
May 15, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 30, 2012
Results First Submitted that Met QC Criteria
Jan 16, 2013
Results First Posted Date
Jan 17, 2013Estimated
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
Mar 21, 2017
Last Update Posted Date
Apr 17, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab injection in patients with clinically significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus (Type 1 or 2). This study is identical in design to study NCT00473330 (Protocol ID FVF4170g).
The open-label extension phase of the study was stopped after receiving FDA approval of the study drug (ranibizumab) for diabetic macular edema.
Detailed Description
This study is composed of 3 phases: (1) A 24-month controlled treatment period (monthly treatment with ranibizumab 0.3 mg, ranibizumab 0.5 mg, or sham injection) followed by (2) a 12-month treatment period in which patients randomized to the sham group who had not discontinued from treatment (still masked) could choose to receive monthly ranibizumab 0.5 mg while the 2 ranibizumab treatment groups continued on the same treatment they received in the first 2 years. Patients who had not discontinued treatment by Month 36 were eligible to continue treatment with ranibizumab 0.5 mg as needed (pro re nata, PRN) in (3) an extension phase of the study for up to 2 more years, resulting in up to 5 years possible total treatment time for some patients.
As per the protocol, Genentech terminated the study approximately 30 days after approval of ranibizumab for diabetic macular edema in the United States.
Conditions Module
Conditions
Diabetes Mellitus
Macular Edema
Keywords
Lucentis
DME
Diabetes
Vision loss
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
382Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ranibizumab 0.3 mg
Experimental
Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
Drug: Ranibizumab
Ranibizumab 0.5 mg
Experimental
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
Drug: Ranibizumab
Sham injection/ranibizumab 0.5 mg
Sham Comparator
Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
Drug: Sham injection
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ranibizumab
Drug
Sterile solution for intravitreal injection.
Ranibizumab 0.3 mg
Ranibizumab 0.5 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Baseline to Month 24
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Willingness to provide written informed consent and, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, and in other countries, as applicable according to national laws.
Age ≥ 18 years.
Diabetes mellitus (Type 1 or 2) .
Retinal thickening secondary to diabetes mellitus (DME) involving the center of the fovea with central macular thickness ≥ 275 µm in the center subfield as assessed on optical coherence tomography (OCT).
Best corrected visual acuity (BCVA) score in the study eye of 20/40 to 20/320 approximate Snellen equivalent using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at an initial testing distance of 4 meters.
Decrease in vision determined to be primarily the result of DME and not to other causes.
For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study.
Ability (in the opinion of the investigator) and willingness to return for all scheduled visits and assessments.
Exclusion Criteria:
History of vitreoretinal surgery in the study eye.
Panretinal photocoagulation (PRP) or macular laser photocoagulation in the study eye within 3 months of screening.
Previous use of intraocular corticosteroids in the study eye (eg, triamcinolone acetonide [TA]) within 3 months of screening.
Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of the Day 0 (first day of treatment) visit.
Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR.
Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in the study eye.
Concurrent Ocular Conditions
Vitreomacular traction or epiretinal membrane in the study eye.
Ocular inflammation (including trace or above) in the study eye.
History of idiopathic or autoimmune uveitis in either eye.
Structural damage to the center of the macula in the study eye that is likely to preclude improvement in VA following the resolution of macular edema, including atrophy of the retinal pigment epithelium (RPE), subretinal fibrosis, or organized hard-exudate plaque.
Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization (CNV) of any cause (eg, age-related macular degeneration (AMD), ocular histoplasmosis, or pathologic myopia).
Concurrent disease in the study eye that would compromise visual acuity or require medical or surgical intervention during the study period.
Cataract surgery in the study eye within 3 months, yttrium-aluminum-garnet (YAG) laser capsulotomy within the past 2 months, or any other intraocular surgery within the 90 days preceding Day 0.
Aphakia or absence of the posterior capsule in the study eye.
Uncontrolled glaucoma or previous filtration surgery in the study eye.
Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia.
Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection.
Uncontrolled blood pressure.
History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.
Uncontrolled diabetes mellitus.
Renal failure requiring dialysis or renal transplant.
Participation in an investigational trial within 30 days prior to screening that involved treatment with any drug (excluding vitamins and minerals) or device.
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk from treatment complications.
Pregnancy or lactation.
History of allergy to fluorescein.
History of allergy to ranibizumab injection or related molecule.
Bressler N, Haskova Z, Kapre A, Gentile B. Clinically Meaningful Change Estimates for the National Eye Institute Visual Function Questionnaire-25 in Patients With Diabetic Macular Edema. Transl Vis Sci Technol. 2024 Dec 2;13(12):27. doi: 10.1167/tvst.13.12.27.
Stockwell AD, Chang MC, Mahajan A, Forrest W, Anegondi N, Pendergrass RK, Selvaraj S, Reeder J, Wei E, Iglesias VA, Creps NM, Macri L, Neeranjan AN, van der Brug MP, Scales SJ, McCarthy MI, Yaspan BL. Multi-ancestry GWAS analysis identifies two novel loci associated with diabetic eye disease and highlights APOL1 as a high risk locus in patients with diabetic macular edema. PLoS Genet. 2023 Aug 16;19(8):e1010609. doi: 10.1371/journal.pgen.1010609. eCollection 2023 Aug.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Patients were recruited from study sites in the United States, Argentina, Peru, Columbia, Chile, and Peru. There were 47 patients from the Latin American countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Sham Injection/Ranibizumab 0.5 mg
Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
Periods
Title
Milestones
Reasons Not Completed
Core Study
Type
Comment
Milestone Data
STARTED
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
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
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
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Lucentis
Sham injection
Drug
Sham injection/ranibizumab 0.5 mg
Baseline to Month 48
Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48
VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.
Months 24, 36, and 48
Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Baseline to Month 48
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.
Baseline to Month 36
Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48
Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.
Baseline to Month 48
Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36
The severity of diabetic retinopathy was graded on a 10-point scale by the central reading center by comparing patient fundus photographic images with a set of standard images. 1=diabetic retinopathy (DR) severity level 10, 12 (DR absent), 2=DR severity level 14A-14C, 14Z, 15, 20 (DR questionable, microaneurysms only), 3=DR severity level 35A-35F (mild non-proliferative [NP]DR), 4=DR severity level 43A, 43B (moderate NPDR), 5=DR severity level 47A-47D (moderately severe NPDR), 6=DR severity level 53A-53E (severe NPDR), 7=DR severity level 60, 61A, 61B (mild proliferative [P]DR), 8=DR severity level 65A-65C (moderate PDR), 9=DR severity level 71A-71D (high-risk PDR), 10=DR severity level 90 (cannot grade). A lower score indicates less severe diabetic retinopathy.
Baseline to Month 36
Percentage of Patients With Resolution of Leakage at Month 24
Resolution of leakage was defined as total area of fluorescein leakage in the central, inner, and outer subfields of the 0 Disc Area. Leakage was assessed in fluorescein angiographic images by the central reading center.
Baseline to Month 24
Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36
The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3.
Baseline to Month 36
Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Baseline to Month 48
Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.
Month 36 to Month 48
Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Month 36 to Month 48
Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48
Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.
Talcott KE, Valentim CCS, Hill L, Stoilov I, Singh RP. Baseline Diabetic Retinopathy Severity and Time to Diabetic Macular Edema Resolution with Ranibizumab Treatment: A Meta-Analysis. Ophthalmol Retina. 2023 Jul;7(7):605-611. doi: 10.1016/j.oret.2023.02.003. Epub 2023 Feb 10.
Gonzalez VH, Wang PW, Ruiz CQ. Panretinal Photocoagulation for Diabetic Retinopathy in the RIDE and RISE Trials: Not "1 and Done". Ophthalmology. 2021 Oct;128(10):1448-1457. doi: 10.1016/j.ophtha.2019.08.010. Epub 2019 Aug 21.
Wykoff CC, Eichenbaum DA, Roth DB, Hill L, Fung AE, Haskova Z. Ranibizumab Induces Regression of Diabetic Retinopathy in Most Patients at High Risk of Progression to Proliferative Diabetic Retinopathy. Ophthalmol Retina. 2018 Oct;2(10):997-1009. doi: 10.1016/j.oret.2018.06.005. Epub 2018 Aug 1.
Moshfeghi AA, Shapiro H, Lemmon LA, Gune S. Impact of Cataract Surgery during Treatment with Ranibizumab in Patients with Diabetic Macular Edema. Ophthalmol Retina. 2018 Feb;2(2):86-90. doi: 10.1016/j.oret.2017.05.003. Epub 2017 Jul 27.
Sun JK, Wang PW, Taylor S, Haskova Z. Durability of Diabetic Retinopathy Improvement with As-Needed Ranibizumab: Open-Label Extension of RIDE and RISE Studies. Ophthalmology. 2019 May;126(5):712-720. doi: 10.1016/j.ophtha.2018.10.041. Epub 2018 Nov 9.
Reddy RK, Pieramici DJ, Gune S, Ghanekar A, Lu N, Quezada-Ruiz C, Baumal CR. Efficacy of Ranibizumab in Eyes with Diabetic Macular Edema and Macular Nonperfusion in RIDE and RISE. Ophthalmology. 2018 Oct;125(10):1568-1574. doi: 10.1016/j.ophtha.2018.04.002. Epub 2018 May 8.
Singh RP, Habbu K, Ehlers JP, Lansang MC, Hill L, Stoilov I. The Impact of Systemic Factors on Clinical Response to Ranibizumab for Diabetic Macular Edema. Ophthalmology. 2016 Jul;123(7):1581-7. doi: 10.1016/j.ophtha.2016.03.038. Epub 2016 May 24.
Pieramici DJ, Wang PW, Ding B, Gune S. Visual and Anatomic Outcomes in Patients with Diabetic Macular Edema with Limited Initial Anatomic Response to Ranibizumab in RIDE and RISE. Ophthalmology. 2016 Jun;123(6):1345-50. doi: 10.1016/j.ophtha.2016.02.007. Epub 2016 Mar 15.
Bressler NM, Varma R, Mitchell P, Suner IJ, Dolan C, Ward J, Ferreira A, Ehrlich JS, Turpcu A. Effect of Ranibizumab on the Decision to Drive and Vision Function Relevant to Driving in Patients With Diabetic Macular Edema: Report From RESTORE, RIDE, and RISE Trials. JAMA Ophthalmol. 2016 Feb;134(2):160-6. doi: 10.1001/jamaophthalmol.2015.4636.
Boyer DS, Nguyen QD, Brown DM, Basu K, Ehrlich JS; RIDE and RISE Research Group. Outcomes with As-Needed Ranibizumab after Initial Monthly Therapy: Long-Term Outcomes of the Phase III RIDE and RISE Trials. Ophthalmology. 2015 Dec;122(12):2504-13.e1. doi: 10.1016/j.ophtha.2015.08.006. Epub 2015 Oct 9.
Bansal AS, Khurana RN, Wieland MR, Wang PW, Van Everen SA, Tuomi L. Influence of Glycosylated Hemoglobin on the Efficacy of Ranibizumab for Diabetic Macular Edema: A Post Hoc Analysis of the RIDE/RISE Trials. Ophthalmology. 2015 Aug;122(8):1573-9. doi: 10.1016/j.ophtha.2015.04.029. Epub 2015 Jun 4.
Bressler NM, Varma R, Suner IJ, Dolan CM, Ward J, Ehrlich JS, Colman S, Turpcu A; RIDE and RISE Research Groups. Vision-related function after ranibizumab treatment for diabetic macular edema: results from RIDE and RISE. Ophthalmology. 2014 Dec;121(12):2461-72. doi: 10.1016/j.ophtha.2014.07.008. Epub 2014 Aug 20.
Brown DM, Nguyen QD, Marcus DM, Boyer DS, Patel S, Feiner L, Schlottmann PG, Rundle AC, Zhang J, Rubio RG, Adamis AP, Ehrlich JS, Hopkins JJ; RIDE and RISE Research Group. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials: RISE and RIDE. Ophthalmology. 2013 Oct;120(10):2013-22. doi: 10.1016/j.ophtha.2013.02.034. Epub 2013 May 22.
Ip MS, Domalpally A, Hopkins JJ, Wong P, Ehrlich JS. Long-term effects of ranibizumab on diabetic retinopathy severity and progression. Arch Ophthalmol. 2012 Sep;130(9):1145-52. doi: 10.1001/archophthalmol.2012.1043.
FG001
Ranibizumab 0.3 mg
Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
FG002
Ranibizumab 0.5 mg
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
FG000130 subjects
FG001125 subjects
FG002127 subjects
COMPLETED
FG000102 subjects
FG00198 subjects
FG00298 subjects
NOT COMPLETED
FG00028 subjects
FG00127 subjects
FG00229 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0011 subjects
FG0021 subjects
Death
FG0003 subjects
FG0015 subjects
FG00210 subjects
Lost to Follow-up
FG0003 subjects
FG0013 subjects
FG0023 subjects
Physician Decision
FG0001 subjects
FG0012 subjects
FG0022 subjects
Subject non-compliance
FG0005 subjects
FG0012 subjects
FG0021 subjects
Subject needed other treatment
FG0001 subjects
FG0013 subjects
FG0022 subjects
Subject's decision
FG00012 subjects
FG00111 subjects
FG00210 subjects
Open-label Extension Through Month 48
Type
Comment
Milestone Data
STARTED
FG00088 subjectsNot all participants who completed the core study entered the optional open-label extension.
FG00183 subjectsNot all participants who completed the core study entered the optional open-label extension.
FG00284 subjectsNot all participants who completed the core study entered the optional open-label extension.
COMPLETED
FG00038 subjects
FG00142 subjects
FG00237 subjects
NOT COMPLETED
FG00050 subjects
FG00141 subjects
FG00247 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
Death
FG000
Open-label Extension Through Month 60
Type
Comment
Milestone Data
STARTED
FG00088 subjectsNot all participants who completed the core study entered the optional open-label extension.
FG00183 subjectsNot all participants who completed the core study entered the optional open-label extension.
FG00284 subjectsNot all participants who completed the core study entered the optional open-label extension.
COMPLETED
FG0002 subjects
FG0011 subjects
FG0022 subjects
NOT COMPLETED
FG00086 subjects
FG00182 subjects
FG00282 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
Death
FG000
The Baseline Characteristics of the patients enrolled in the open-label extension phase (N=88, 83, 84 patients originally randomized to the ranibizumab 0.3 mg, ranibizumab 0.5 mg, and sham injection groups, respectively) were similar to the Baseline Characteristics of the patients enrolled in the core study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
BG001
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
BG002
Sham Injection
Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000125
BG001127
BG002130
BG003382
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
Title
Measurements
BG00062.7± 11.1
BG00161.8± 10.1
BG00263.5± 10.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00052
BG00147
BG002
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
Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward.
Posted
Number
95% Confidence Interval
Percentage of patients
Baseline to Month 24
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
OG001
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
OG002
Sham Injection
Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
Units
Counts
Participants
OG000125
OG001127
OG002130
Title
Denominators
Categories
Title
Measurements
OG00033.6(25.3 to 41.9)
OG00145.7(37.0 to 54.3)
OG00212.3(6.7 to 18.0)
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
OG002
Cochran-Mantel-Haenszel
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
<0.0001
An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.
Difference in percentage at Month 24
20.8
2-Sided
95
11.4
30.2
The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.
Secondary
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.
Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.
Posted
Mean
Standard Deviation
Letters
Baseline to Month 48
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG001
Ranibizumab 0.5 mg
Secondary
Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48
VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.
Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.
Posted
Number
95% Confidence Interval
Percentage of patients
Months 24, 36, and 48
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG001
Secondary
Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.
Posted
Number
95% Confidence Interval
Percentage of patients
Baseline to Month 48
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG001
Ranibizumab 0.5 mg
Secondary
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.
Subgroup of the intent-to-treat population: All randomized patients with focal edema at baseline, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.
Posted
Mean
Standard Deviation
Letters
Baseline to Month 36
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
OG001
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
Secondary
Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48
Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.
Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.
Posted
Mean
Standard Deviation
µm
Baseline to Month 48
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG001
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive Ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Secondary
Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36
The severity of diabetic retinopathy was graded on a 10-point scale by the central reading center by comparing patient fundus photographic images with a set of standard images. 1=diabetic retinopathy (DR) severity level 10, 12 (DR absent), 2=DR severity level 14A-14C, 14Z, 15, 20 (DR questionable, microaneurysms only), 3=DR severity level 35A-35F (mild non-proliferative [NP]DR), 4=DR severity level 43A, 43B (moderate NPDR), 5=DR severity level 47A-47D (moderately severe NPDR), 6=DR severity level 53A-53E (severe NPDR), 7=DR severity level 60, 61A, 61B (mild proliferative [P]DR), 8=DR severity level 65A-65C (moderate PDR), 9=DR severity level 71A-71D (high-risk PDR), 10=DR severity level 90 (cannot grade). A lower score indicates less severe diabetic retinopathy.
Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.
Posted
Number
95% Confidence Interval
Percentage of patients
Baseline to Month 36
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
OG001
Secondary
Percentage of Patients With Resolution of Leakage at Month 24
Resolution of leakage was defined as total area of fluorescein leakage in the central, inner, and outer subfields of the 0 Disc Area. Leakage was assessed in fluorescein angiographic images by the central reading center.
Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.
Posted
Number
95% Confidence Interval
Percentage of patients
Baseline to Month 24
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
OG001
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
OG002
Sham Injection
Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
Secondary
Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36
The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3.
Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.
Posted
Mean
Standard Deviation
Treatments
Baseline to Month 36
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
OG001
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
OG002
Sham Injection
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
Secondary
Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.
Posted
Number
95% Confidence Interval
Percentage of patients
Baseline to Month 48
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG001
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Secondary
Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.
Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.
Posted
Mean
Standard Deviation
Letters
Month 36 to Month 48
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG001
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Secondary
Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.
Posted
Number
95% Confidence Interval
Percentage of patients
Month 36 to Month 48
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG001
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Secondary
Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48
Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.
Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.
Posted
Mean
Standard Deviation
µm
Month 36 to Month 48
ID
Title
Description
OG000
Ranibizumab 0.3 mg
Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG001
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Time Frame
Adverse events were recorded from the first day of treatment through Month 60. The sham Months 0-36 group includes patients randomized to sham. The sham Months 0-24 group includes patients who received sham during the first 24 months of the study.
Description
The adverse events tables have been updated to MedDRA version 15.1 to include safety data from the open-label extension phase. Late reported adverse events from the 36-month period have also been included.
Safety evaluable population: All randomized patients who received at least 1 study treatment.
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
Sham Injection - Months 0-24
Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
54
127
123
127
EG001
Sham Injection/Ranibizumab 0.5 mg - Months 0-36
Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
68
127
123
127
EG002
Ranibizumab 0.3 mg - Months 0-36
Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
54
125
120
125
EG003
Ranibizumab 0.5 mg - Months 0-36
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
67
124
121
124
EG004
Sham Injection/Ranibizumab 0.5 mg - Months 37-60
Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
19
88
65
88
EG005
Ranibizumab 0.3 mg - Months 37-60
Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
31
83
63
83
EG006
Ranibizumab 0.5 mg - Months 37-60
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
18
84
62
84
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0022 affected125 at risk
EG0031 affected124 at risk
EG0040 affected88 at risk
EG0050 affected83 at risk
EG0060 affected84 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0012 affected127 at risk
EG0024 affected125 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0002 affected127 at risk
EG0013 affected127 at risk
EG0020 affected125 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0012 affected127 at risk
EG0023 affected125 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0006 affected127 at risk
EG0017 affected127 at risk
EG0023 affected125 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0013 affected127 at risk
EG0022 affected125 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Intracardiac thrombus
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Goitre
Endocrine disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Angle closure glaucoma (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Blindness unilateral (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Cataract (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Choroidal neovascularisation (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Corneal opacity (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Diabetic retinal oedema (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Glaucoma (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Macular ischaemia (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Macular oedema (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Macular oedema (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Papilloedema (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Retinal detachment (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Retinal haemorrhage (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Visual acuity reduced (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0022 affected125 at risk
EG003
Visual acuity reduced (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0002 affected127 at risk
EG0012 affected127 at risk
EG0020 affected125 at risk
EG003
Vitreous haemorrhage (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0002 affected127 at risk
EG0013 affected127 at risk
EG00210 affected125 at risk
EG003
Appendiceal mucocoele
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0002 affected127 at risk
EG0012 affected127 at risk
EG0021 affected125 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Peptic ulcer haemorrhage
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Chest pain
General disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Oedema peripheral
General disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0012 affected127 at risk
EG0021 affected125 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Abscess
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Bone abscess
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0003 affected127 at risk
EG0013 affected127 at risk
EG0023 affected125 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Empyema
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Endophthalmitis (F)
Infections and infestations
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Endophthalmitis (S)
Infections and infestations
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0023 affected125 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Gangrene
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Infected skin ulcer
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Infection
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Kidney infection
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Localised infection
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0012 affected127 at risk
EG0020 affected125 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Osteomyelitis chronic
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0005 affected127 at risk
EG0015 affected127 at risk
EG0021 affected125 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Sepsis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Sepsis syndrome
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0022 affected125 at risk
EG003
Wound infection
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Carbon monoxide poisoning
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Cataract traumatic (S)
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Corneal abrasion (S)
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Drug administration error
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Expired drug administered
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0012 affected127 at risk
EG0021 affected125 at risk
EG003
Medication error (S)
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Post procedural complication (S)
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Procedural complication (S)
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Intraocular pressure increased (S)
Investigations
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0022 affected125 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0002 affected127 at risk
EG0012 affected127 at risk
EG0021 affected125 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Monarthritis
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0002 affected127 at risk
EG0012 affected127 at risk
EG0020 affected125 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Acute leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Bladder papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Non-hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Tongue neoplasm malignant stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Carotid artery occlusion
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0002 affected127 at risk
EG0012 affected127 at risk
EG0023 affected125 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Hemiplegia
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Syncope
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0022 affected125 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0002 affected127 at risk
EG0013 affected127 at risk
EG0021 affected125 at risk
EG003
VIIth nerve paralysis
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Major depression
Psychiatric disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Diabetic nephropathy
Renal and urinary disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (15.1)
Systematic Assessment
EG0003 affected127 at risk
EG0014 affected127 at risk
EG0023 affected125 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (15.1)
Systematic Assessment
EG0002 affected127 at risk
EG0012 affected127 at risk
EG0022 affected125 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0012 affected127 at risk
EG0022 affected125 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Hospitalisation
Surgical and medical procedures
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Nephroureterectomy
Surgical and medical procedures
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0022 affected125 at risk
EG003
Femoral artery occlusion
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Hypertension
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0022 affected125 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Hypotension
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Vascular insufficiency
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Vitreous haemorrhage (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0003 affected127 at risk
EG0014 affected127 at risk
EG0021 affected125 at risk
EG003
Retinal detachment (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0006 affected127 at risk
EG0017 affected127 at risk
EG0028 affected125 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0020 affected125 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0021 affected125 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Proctocolitis
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Death
General disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Multi-organ failure
General disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0001 affected127 at risk
EG0011 affected127 at risk
EG0021 affected125 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Influenza
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Diabetic foot infection
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Endocarditis staphylococcal
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Neck injury
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Skull fractured base
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Endometrial cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Hepatic neoplasm malignant recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Hypoglycaemic coma
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Hypoglycaemic encephalopathy
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Stent placement
Surgical and medical procedures
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Retinal vein occlusion (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0000 affected127 at risk
EG0010 affected127 at risk
EG0020 affected125 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (15.1)
Systematic Assessment
EG00013 affected127 at risk
EG00116 affected127 at risk
EG00213 affected125 at risk
EG00322 affected124 at risk
EG0043 affected88 at risk
EG0052 affected83 at risk
EG0063 affected84 at risk
Atrial fibrillation
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0004 affected127 at risk
EG0017 affected127 at risk
EG0024 affected125 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0007 affected127 at risk
EG0018 affected127 at risk
EG0027 affected125 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (15.1)
Systematic Assessment
EG0004 affected127 at risk
EG0018 affected127 at risk
EG0026 affected125 at risk
EG003
Cataract (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG00029 affected127 at risk
EG00132 affected127 at risk
EG00238 affected125 at risk
EG003
Cataract (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00035 affected127 at risk
EG00139 affected127 at risk
EG00231 affected125 at risk
EG003
Cataract cortical (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0005 affected127 at risk
EG0018 affected127 at risk
EG00210 affected125 at risk
EG003
Cataract cortical (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0005 affected127 at risk
EG0016 affected127 at risk
EG0028 affected125 at risk
EG003
Cataract nuclear (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0001 affected127 at risk
EG0012 affected127 at risk
EG00210 affected125 at risk
EG003
Cataract nuclear (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0003 affected127 at risk
EG0014 affected127 at risk
EG0026 affected125 at risk
EG003
Cataract subcapsular (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0003 affected127 at risk
EG0013 affected127 at risk
EG0027 affected125 at risk
EG003
Conjunctival haemorrhage (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0003 affected127 at risk
EG00111 affected127 at risk
EG0028 affected125 at risk
EG003
Conjunctival haemorrhage (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00040 affected127 at risk
EG00145 affected127 at risk
EG00254 affected125 at risk
EG003
Diabetic retinal oedema (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG00019 affected127 at risk
EG00120 affected127 at risk
EG00225 affected125 at risk
EG003
Diabetic retinal oedema (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0008 affected127 at risk
EG0018 affected127 at risk
EG0028 affected125 at risk
EG003
Diabetic retinopathy (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0005 affected127 at risk
EG0015 affected127 at risk
EG0028 affected125 at risk
EG003
Dry eye (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0008 affected127 at risk
EG00110 affected127 at risk
EG0025 affected125 at risk
EG003
Dry eye (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0006 affected127 at risk
EG0018 affected127 at risk
EG0028 affected125 at risk
EG003
Eye irritation (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0004 affected127 at risk
EG0016 affected127 at risk
EG0028 affected125 at risk
EG003
Eye pain (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00010 affected127 at risk
EG00112 affected127 at risk
EG00214 affected125 at risk
EG003
Foreign body sensation in eyes (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0007 affected127 at risk
EG0018 affected127 at risk
EG00210 affected125 at risk
EG003
Lacrimation increased (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0004 affected127 at risk
EG0016 affected127 at risk
EG0027 affected125 at risk
EG003
Macular fibrosis (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0005 affected127 at risk
EG0016 affected127 at risk
EG00213 affected125 at risk
EG003
Macular fibrosis (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00011 affected127 at risk
EG00114 affected127 at risk
EG0027 affected125 at risk
EG003
Macular oedema (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG00028 affected127 at risk
EG00137 affected127 at risk
EG00246 affected125 at risk
EG003
Macular oedema (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00026 affected127 at risk
EG00133 affected127 at risk
EG00232 affected125 at risk
EG003
Ocular hyperaemia (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00010 affected127 at risk
EG00110 affected127 at risk
EG0025 affected125 at risk
EG003
Posterior capsule opacification (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0004 affected127 at risk
EG0016 affected127 at risk
EG0027 affected125 at risk
EG003
Retinal exudates (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG00016 affected127 at risk
EG00118 affected127 at risk
EG00223 affected125 at risk
EG003
Retinal exudates (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00015 affected127 at risk
EG00119 affected127 at risk
EG00222 affected125 at risk
EG003
Retinal haemorrhage (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG00020 affected127 at risk
EG00131 affected127 at risk
EG00232 affected125 at risk
EG003
Retinal haemorrhage (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00022 affected127 at risk
EG00126 affected127 at risk
EG00222 affected125 at risk
EG003
Retinal neovascularisation (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG00010 affected127 at risk
EG00113 affected127 at risk
EG00213 affected125 at risk
EG003
Retinal neovascularisation (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0007 affected127 at risk
EG0018 affected127 at risk
EG0021 affected125 at risk
EG003
Vision blurred (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0005 affected127 at risk
EG0015 affected127 at risk
EG00210 affected125 at risk
EG003
Vitreous detachment (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG00019 affected127 at risk
EG00120 affected127 at risk
EG00213 affected125 at risk
EG003
Vitreous detachment (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00019 affected127 at risk
EG00122 affected127 at risk
EG00214 affected125 at risk
EG003
Vitreous floaters (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0007 affected127 at risk
EG0018 affected127 at risk
EG0023 affected125 at risk
EG003
Vitreous floaters (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0004 affected127 at risk
EG0016 affected127 at risk
EG00210 affected125 at risk
EG003
Vitreous haemorrhage (F)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG00012 affected127 at risk
EG00116 affected127 at risk
EG00218 affected125 at risk
EG003
Vitreous haemorrhage (S)
Eye disorders
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00016 affected127 at risk
EG00117 affected127 at risk
EG0023 affected125 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0007 affected127 at risk
EG0019 affected127 at risk
EG00214 affected125 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0006 affected127 at risk
EG0016 affected127 at risk
EG0023 affected125 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0006 affected127 at risk
EG0016 affected127 at risk
EG0026 affected125 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG00014 affected127 at risk
EG00116 affected127 at risk
EG00214 affected125 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (15.1)
Systematic Assessment
EG0009 affected127 at risk
EG00110 affected127 at risk
EG0026 affected125 at risk
EG003
Oedema peripheral
General disorders
MedDRA (15.1)
Systematic Assessment
EG0004 affected127 at risk
EG0014 affected127 at risk
EG0029 affected125 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (15.1)
Systematic Assessment
EG0006 affected127 at risk
EG0017 affected127 at risk
EG0022 affected125 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (15.1)
Systematic Assessment
EG0005 affected127 at risk
EG0016 affected127 at risk
EG00212 affected125 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0004 affected127 at risk
EG0016 affected127 at risk
EG0028 affected125 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0004 affected127 at risk
EG0019 affected127 at risk
EG0025 affected125 at risk
EG003
Influenza
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0007 affected127 at risk
EG0019 affected127 at risk
EG00210 affected125 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0006 affected127 at risk
EG00110 affected127 at risk
EG00216 affected125 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG0004 affected127 at risk
EG0016 affected127 at risk
EG0025 affected125 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG00012 affected127 at risk
EG00114 affected127 at risk
EG0029 affected125 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG00012 affected127 at risk
EG00114 affected127 at risk
EG00212 affected125 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (15.1)
Systematic Assessment
EG00019 affected127 at risk
EG00124 affected127 at risk
EG00213 affected125 at risk
EG003
Corneal abrasion (S)
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG0006 affected127 at risk
EG0018 affected127 at risk
EG0027 affected125 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0003 affected127 at risk
EG0018 affected127 at risk
EG00210 affected125 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (15.1)
Systematic Assessment
EG0002 affected127 at risk
EG0013 affected127 at risk
EG0021 affected125 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (15.1)
Systematic Assessment
EG0005 affected127 at risk
EG0016 affected127 at risk
EG0028 affected125 at risk
EG003
Blood glucose increased
Investigations
MedDRA (15.1)
Systematic Assessment
EG0008 affected127 at risk
EG0019 affected127 at risk
EG00210 affected125 at risk
EG003
Intraocular pressure increased (F)
Investigations
MedDRA (15.1)
Systematic Assessment
(F)=fellow eye
EG0006 affected127 at risk
EG0017 affected127 at risk
EG0027 affected125 at risk
EG003
Intraocular pressure increased (S)
Investigations
MedDRA (15.1)
Systematic Assessment
(S)=study eye
EG00014 affected127 at risk
EG00117 affected127 at risk
EG00220 affected125 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG00022 affected127 at risk
EG00125 affected127 at risk
EG00219 affected125 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0007 affected127 at risk
EG0018 affected127 at risk
EG00213 affected125 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0004 affected127 at risk
EG0014 affected127 at risk
EG0025 affected125 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0003 affected127 at risk
EG0014 affected127 at risk
EG0027 affected125 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Systematic Assessment
EG0006 affected127 at risk
EG0017 affected127 at risk
EG0025 affected125 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Systematic Assessment
EG00011 affected127 at risk
EG00114 affected127 at risk
EG0025 affected125 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0004 affected127 at risk
EG0016 affected127 at risk
EG0027 affected125 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0004 affected127 at risk
EG0015 affected127 at risk
EG0025 affected125 at risk
EG003
Headache
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0007 affected127 at risk
EG00110 affected127 at risk
EG00210 affected125 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (15.1)
Systematic Assessment
EG0004 affected127 at risk
EG0016 affected127 at risk
EG0029 affected125 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (15.1)
Systematic Assessment
EG0008 affected127 at risk
EG0018 affected127 at risk
EG0026 affected125 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (15.1)
Systematic Assessment
EG0007 affected127 at risk
EG0017 affected127 at risk
EG0025 affected125 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0008 affected127 at risk
EG00110 affected127 at risk
EG00217 affected125 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Systematic Assessment
EG0007 affected127 at risk
EG0018 affected127 at risk
EG0023 affected125 at risk
EG003
Hypertension
Vascular disorders
MedDRA (15.1)
Systematic Assessment
EG00031 affected127 at risk
EG00135 affected127 at risk
EG00233 affected125 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (15.1)
Systematic Assessment
EG0005 affected127 at risk
EG0017 affected127 at risk
EG0022 affected125 at risk
EG003
Blood urea increased
Investigations
MedDRA (15.1)
Systematic Assessment
EG0005 affected127 at risk
EG0016 affected127 at risk
EG0028 affected125 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Communications
Genentech, Inc.
800 821-8590
genentech@druginfo.com
ID
Term
D003920
Diabetes Mellitus
D008269
Macular Edema
D014786
Vision Disorders
Ancestor Terms
ID
Term
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
D008268
Macular Degeneration
D012162
Retinal Degeneration
D012164
Retinal Diseases
D005128
Eye Diseases
D012678
Sensation Disorders
D009461
Neurologic Manifestations
D009422
Nervous System Diseases
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069579
Ranibizumab
C005703
salicylhydroxamic acid
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0013 subjects
FG0023 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0021 subjects
Subject's Decision
FG0005 subjects
FG0011 subjects
FG0026 subjects
Sponsor's Decision to Terminate Study
FG00041 subjects
FG00134 subjects
FG00236 subjects
Subject Required Other Intervention
FG0002 subjects
FG0011 subjects
FG0020 subjects
1 subjects
FG0017 subjects
FG0024 subjects
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0021 subjects
Subject's Decision
FG0007 subjects
FG0011 subjects
FG0026 subjects
Sponsor's Decision to Terminate Study
FG00075 subjects
FG00170 subjects
FG00269 subjects
Subject Required Other Intervention
FG0002 subjects
FG0011 subjects
FG0020 subjects
62.7
± 10.7
64
BG003163
Male
BG00073
BG00180
BG00266
BG003219
Superiority or Other
OG001
OG002
Cochran-Mantel-Haenszel
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
<0.0001
An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.
Difference in percentage at Month 24
33.3
2-Sided
95
23.8
42.8
The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.
Superiority or Other
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG002
Sham Injection
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
OG003
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Units
Counts
Participants
OG000125
OG001127
OG002130
OG003130
Title
Denominators
Categories
Month 24
Title
Measurements
OG00010.9± 10.4
OG00112.0± 14.9
OG0022.3± 14.2
OG003NA± NANA = not applicable, see reporting groups.
Month 36
Title
Measurements
OG00010.6± 12.9
OG00111.4± 16.3
OG002NA± NANA = not applicable, see reporting groups.
OG003
Month 48 (n=34,39,39,0)
Title
Measurements
OG00011.1± 12.0
OG00112.4± 9.7
OG002NA± NANA = not applicable, see reporting groups.
OG003
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
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.
ANOVA
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
<0.0001
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Mean Difference (Final Values)
8.5
2-Sided
95
5.4
11.5
Superiority or Other
OG001
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.
ANOVA
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
<0.0001
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Mean Difference (Final Values)
9.9
2-Sided
95
6.4
13.3
Superiority or Other
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG002
Sham Injection
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
OG003
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Units
Counts
Participants
OG000125
OG001127
OG002130
OG003130
Title
Denominators
Categories
Month 24
Title
Measurements
OG00054.4(45.7 to 63.1)
OG00162.2(53.8 to 70.6)
OG00234.6(26.4 to 42.8)
OG003NA(NA to NA)NA = not applicable, see reporting groups.
Month 36
Title
Measurements
OG00055.2(46.5 to 63.9)
OG00159.1(50.5 to 67.6)
OG002NA(NA to NA)NA = not applicable, see reporting groups.
OG003
Month 48 (n=39,39,0,34)
Title
Measurements
OG00064.1(47.2 to 78.8)
OG00156.4(39.6 to 72.2)
OG002NA(NA to NA)NA = not applicable, see reporting groups.
OG003
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
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.
Cochran-Mantel-Haenszel
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
0.0002
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Difference in percentage at Month 24
21.4
2-Sided
95
10.8
31.9
The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.
Superiority or Other
OG001
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.
Cochran-Mantel-Haenszel
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
<0.0001
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Difference in percentage at Month 24
27.1
2-Sided
95
16.4
37.9
The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.
Superiority or Other
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
OG002
Sham Injection
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
OG003
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Units
Counts
Participants
OG000125
OG001127
OG002130
OG003130
Title
Denominators
Categories
Month 24
Title
Measurements
OG00098.4(96.2 to 100.0)
OG00196.1(92.7 to 99.4)
OG00291.5(86.8 to 96.3)
OG003NA(NA to NA)NA = not applicable, see reporting groups.
Month 36
Title
Measurements
OG00096.8(93.7 to 99.9)
OG00196.1(92.7 to 99.4)
OG002NA(NA to NA)NA = not applicable, see reporting groups.
OG003
Month 48 (n=39,39,0,34)
Title
Measurements
OG00097.4(86.5 to 99.9)
OG00197.4(86.5 to 99.9)
OG002NA(NA to NA)NA = not applicable, see reporting groups.
OG003
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
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.
Cochran-Mantel-Haenszel
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
0.0119
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Difference in percentage at Month 24
7.1
2-Sided
95
1.7
12.6
The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.
Superiority or Other
OG001
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.
Cochran-Mantel-Haenszel
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
0.1384
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Difference in percentage at Month 24
4.5
2-Sided
95
-1.2
10.1
The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.
Superiority or Other
OG002
Sham Injection
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
OG003
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
Units
Counts
Participants
OG00044
OG00137
OG00242
OG00342
Title
Denominators
Categories
Month 24
Title
Measurements
OG00010.5± 11.9
OG00112.8± 11.0
OG0021.9± 17.0
OG003NA± NANA = not applicable, see reporting groups.
Month 36
Title
Measurements
OG00010.8± 12.1
OG00110.9± 16.6
OG002NA± NANA = not applicable, see reporting groups.
OG003
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
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.
ANOVA
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
0.0102
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Mean Difference (Final Values)
8.3
2-Sided
95
2.0
14.6
Superiority or Other
OG001
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.
ANOVA
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
0.0005
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Mean Difference (Final Values)
11.2
2-Sided
95
5.1
17.3
Superiority or Other
OG002
Sham Injection
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
OG003
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Units
Counts
Participants
OG000125
OG001127
OG002130
OG003130
Title
Denominators
Categories
Month 24
Title
Measurements
OG000-259.8± 169.3
OG001-270.7± 201.6
OG002-125.8± 198.3
OG003NA± NANA = not applicable, see reporting groups.
Month 36
Title
Measurements
OG000-261.8± 180.8
OG001-266.7± 207.8
OG002NA± NANA = not applicable, see reporting groups.
OG003
Month 48 (n=38,39,0,33)
Title
Measurements
OG000-251.4± 173.8
OG001-291.6± 200.7
OG002NA± NANA = not applicable, see reporting groups.
OG003
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
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.
ANCOVA
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
<0.0001
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Mean Difference (Final Values)
-111.8
2-Sided
95
-151.6
-72.0
Superiority or Other
OG001
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.
ANCOVA
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
<0.0001
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Mean Difference (Final Values)
-132.2
2-Sided
95
-169.7
-94.8
Superiority or Other
Ranibizumab 0.5 mg
Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
OG002
Sham Injection
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
OG003
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
Units
Counts
Participants
OG000117
OG001119
OG002124
OG003124
Title
Denominators
Categories
Month 24
Title
Measurements
OG0001.7(0 to 4.1)
OG0010(0 to 0)
OG0025.6(1.6 to 9.7)
OG003NA(NA to NA)NA = not applicable, see reporting groups.
Month 36
Title
Measurements
OG0000.9(0 to 2.5)
OG0010.8(0 to 2.5)
OG002NA(NA to NA)NA = not applicable, see reporting groups.
OG003
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
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.
Cochran-Mantel-Haenszel
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
0.0853
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Difference in percentage at Month 24
-4.3
2-Sided
95
-9.3
0.8
The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.
Superiority or Other
OG001
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.
Cochran-Mantel-Haenszel
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
0.0073
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Difference in percentage at Month 24
-5.8
2-Sided
95
-9.8
-1.7
The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.
Superiority or Other
Units
Counts
Participants
OG000123
OG001127
OG002129
Title
Denominators
Categories
Title
Measurements
OG00017.1(10.4 to 23.7)
OG00130.7(22.7 to 38.7)
OG0022.3(0 to 4.9)
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
OG002
Cochran-Mantel-Haenszel
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
0.0002
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Difference in percentage at Month 24
14.0
2-Sided
95
6.8
21.1
The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.
Superiority or Other
OG001
OG002
Cochran-Mantel-Haenszel
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
<0.0001
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Difference in percentage at Month 24
28.3
2-Sided
95
20.2
36.4
The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.
Superiority or Other
OG003
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
Units
Counts
Participants
OG000125
OG001127
OG002130
OG003130
Title
Denominators
Categories
Month 24
Title
Measurements
OG0000.7± 1.4
OG0010.3± 0.7
OG0021.6± 1.6
OG003NA± NANA = not applicable, see reporting groups.
Month 36
Title
Measurements
OG0000.9± 1.8
OG0010.4± 0.9
OG002NA± NANA = not applicable, see reporting groups.
OG003
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
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.
ANOVA
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
<0.0001
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Mean Difference (Final Values)
-0.9
2-Sided
95
-1.3
-0.5
Superiority or Other
OG001
OG002
The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.
ANOVA
The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).
<0.0001
To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.
Mean Difference (Final Values)
-1.3
2-Sided
95
-1.6
-1.0
Superiority or Other
OG002
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Units
Counts
Participants
OG000125
OG001127
OG002130
Title
Denominators
Categories
Month 36
Title
Measurements
OG00036.8(28.3 to 45.3)
OG00140.2(31.6 to 48.7)
OG00219.2(12.5 to 26.0)
Month 48 (n=39,39,34)
Title
Measurements
OG00048.7(32.4 to 65.2)
OG00141.0(25.6 to 57.9)
OG00217.6(6.8 to 34.5)
OG002
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Units
Counts
Participants
OG00039
OG00139
OG00234
Title
Denominators
Categories
Title
Measurements
OG000-0.9± 8.3
OG0010.3± 10.7
OG002-2.6± 8.8
OG002
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
Units
Counts
Participants
OG00039
OG00139
OG00234
Title
Denominators
Categories
Title
Measurements
OG00092.3(79.1 to 98.4)
OG00197.4(86.5 to 99.9)
OG00288.2(72.5 to 96.7)
OG002
Sham Injection/Ranibizumab 0.5 mg
Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.