## Protocol Section
### Identification Module
**NCT ID:** NCT02247479

**Acronym:** CHROMA

**Brief Title:** A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

**Official Title:** A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

#### Organization Study ID Info
**ID:** GX29176
#### Organization
**Class:** INDUSTRY
**Full Name:** Hoffmann-La Roche
#### Secondary ID Infos
**ID:** 2014-000107-27
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2018-01-29

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2018-08-16

**Type:** ACTUAL

**Disp First Submit Date:** 2018-08-14
**Disp First Submit QC Date:** 2018-08-14

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-06-26

**Type:** ACTUAL

**Last Update Submit Date:** 2019-06-17

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2018-01-29

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-04-23

**Type:** ACTUAL

**Results First Submit Date:** 2019-01-22

**Results First Submit QC Date:** 2019-04-19

#### Start Date
**Date:** 2014-09-18

**Type:** ACTUAL

**Status Verified Date:** 2019-06

#### Study First Post Date
**Date:** 2014-09-25
**Type:** ESTIMATED
**Study First Submit Date:** 2014-07-15
**Study First Submit QC Date:** 2014-09-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hoffmann-La Roche

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**Brief Summary:** This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

### Conditions Module

**Conditions:**

- Geographic Atrophy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 906

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.

**Intervention Names:**

- Drug: Lampalizumab

**Label:** Lampalizumab Once in Every 4 Weeks (Q4W)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.

**Intervention Names:**

- Drug: Lampalizumab

**Label:** Lampalizumab Once in Every 6 Weeks (Q6W)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants will receive sham comparator Q4W or Q6W for 96 weeks.

**Intervention Names:**

- Other: Sham

**Label:** Sham Comparator

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lampalizumab Once in Every 4 Weeks (Q4W)

- Lampalizumab Once in Every 6 Weeks (Q6W)

**Description:** Participants will receive 10 mg dose of lampalizumab administered intravitreally.

**Name:** Lampalizumab

**Other Names:**

- RO5490249

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Sham Comparator

**Description:** A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.

**Name:** Sham

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).

**Measure:** Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48

**Time Frame:** Baseline, Week 48

**Description:** For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).

**Measure:** Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48

**Time Frame:** Baseline, Week 48

#### Secondary Outcomes

**Description:** Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.

**Measure:** Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48

**Time Frame:** Baseline, Week 48

**Description:** Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48

**Time Frame:** Baseline, Week 48

**Description:** BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48

**Time Frame:** Baseline, Week 48

**Description:** Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48

**Time Frame:** Week 48

**Description:** The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48

**Time Frame:** Baseline, Week 48

**Description:** Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48

**Time Frame:** Week 48

**Description:** MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48

**Time Frame:** Baseline, Week 48

**Description:** MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48

**Time Frame:** Baseline, Week 48

**Description:** NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48

**Time Frame:** Baseline, Week 48

**Description:** NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48

**Time Frame:** Baseline, Week 48

**Description:** NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48

**Time Frame:** Baseline, Week 48

**Description:** The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

**Measure:** Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48

**Time Frame:** Baseline, Week 48

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion Criteria:

Ocular Exclusion Criteria: Study Eye

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
* Previous intravitreal drug delivery (intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria: Both Eyes
* GA in either eye due to causes other than AMD
* Previous treatment with eculizumab, lampalizumab and/or fenretinide

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** Uni of Alabama At Birmingham Clinical Research Unit

**State:** Alabama

**Zip:** 35233

**Location 2:**

**City:** Phoenix

**Country:** United States

**Facility:** Retinal Research Institute, LLC

**State:** Arizona

**Zip:** 85014

**Location 3:**

**City:** Tucson

**Country:** United States

**Facility:** Retina Centers P.C.

**State:** Arizona

**Zip:** 85704

**Location 4:**

**City:** Bakersfield

**Country:** United States

**Facility:** California Retina Consultants

**State:** California

**Zip:** 93309

**Location 5:**

**City:** Beverly Hills

**Country:** United States

**Facility:** Retina-Vitreous Associates Medical Group

**State:** California

**Zip:** 90211

**Location 6:**

**City:** Irvine

**Country:** United States

**Facility:** The Gavin Herbert Eye Institute - UC, Irvine

**State:** California

**Zip:** 92697-4375

**Location 7:**

**City:** Los Angeles

**Country:** United States

**Facility:** Jules Stein Eye Institute/ UCLA

**State:** California

**Zip:** 90095-7000

**Location 8:**

**City:** Oakland

**Country:** United States

**Facility:** East Bay Retina Consultants

**State:** California

**Zip:** 94609

**Location 9:**

**City:** Palm Desert

**Country:** United States

**Facility:** Southern CA Desert Retina Cons

**State:** California

**Zip:** 92211

**Location 10:**

**City:** San Francisco

**Country:** United States

**Facility:** W Coast Retina Med Group Inc

**State:** California

**Zip:** 94107

**Location 11:**

**City:** San Francisco

**Country:** United States

**Facility:** UCSF; Ophthalmology

**State:** California

**Zip:** 94143

**Location 12:**

**City:** Santa Ana

**Country:** United States

**Facility:** Orange County Retina Med Group

**State:** California

**Zip:** 92705

**Location 13:**

**City:** Santa Barbara

**Country:** United States

**Facility:** California Retina Consultants

**State:** California

**Zip:** 93103

**Location 14:**

**City:** Boynton Beach

**Country:** United States

**Facility:** Florida Eye Microsurgical Inst

**State:** Florida

**Zip:** 33426

**Location 15:**

**City:** Fort Myers

**Country:** United States

**Facility:** National Ophthalmic Research Institute

**State:** Florida

**Zip:** 33912

**Location 16:**

**City:** Melbourne

**Country:** United States

**Facility:** Florida Eye Associates

**State:** Florida

**Zip:** 32901

**Location 17:**

**City:** Palm Beach Gardens

**Country:** United States

**Facility:** Retina Care Specialists

**State:** Florida

**Zip:** 33410

**Location 18:**

**City:** Palm Beach Gardens

**Country:** United States

**Facility:** Bascom Palmer Eye Institute

**State:** Florida

**Zip:** 33418

**Location 19:**

**City:** Pensacola

**Country:** United States

**Facility:** Retina Specialty Institute

**State:** Florida

**Zip:** 32503

**Location 20:**

**City:** Plantation

**Country:** United States

**Facility:** Fort Lauderdale Eye Institute

**State:** Florida

**Zip:** 33324

**Location 21:**

**City:** Saint Petersburg

**Country:** United States

**Facility:** Retina Vitreous Assoc of FL

**State:** Florida

**Zip:** 33711

**Location 22:**

**City:** Tallahassee

**Country:** United States

**Facility:** Southern Vitreoretinal Assoc

**State:** Florida

**Zip:** 32308

**Location 23:**

**City:** Tampa

**Country:** United States

**Facility:** Retina Associates of Florida, LLC

**State:** Florida

**Zip:** 33609

**Location 24:**

**City:** Augusta

**Country:** United States

**Facility:** Southeast Retina Center

**State:** Georgia

**Zip:** 30909

**Location 25:**

**City:** Marietta

**Country:** United States

**Facility:** Georgia Retina PC

**State:** Georgia

**Zip:** 30060

**Location 26:**

**City:** 'Aiea

**Country:** United States

**Facility:** Retina Consultants of Hawaii

**State:** Hawaii

**Zip:** 96701

**Location 27:**

**City:** Chicago

**Country:** United States

**Facility:** Northwestern Medical Group/Northwestern University

**State:** Illinois

**Zip:** 60611

**Location 28:**

**City:** Oak Forest

**Country:** United States

**Facility:** University Retina and Macula Associates, PC

**State:** Illinois

**Zip:** 60452

**Location 29:**

**City:** Indianapolis

**Country:** United States

**Facility:** Midwest Eye Institute Northside

**State:** Indiana

**Zip:** 46290

**Location 30:**

**City:** West Des Moines

**Country:** United States

**Facility:** Wolfe Eye Clinic

**State:** Iowa

**Zip:** 50266

**Location 31:**

**City:** Shawnee Mission

**Country:** United States

**Facility:** Retina Associates

**State:** Kansas

**Zip:** 66204

**Location 32:**

**City:** Lexington

**Country:** United States

**Facility:** Lahey Clinic Med Ctr

**State:** Kentucky

**Zip:** 02421

**Location 33:**

**City:** Lexington

**Country:** United States

**Facility:** Retina Associates of Kentucky

**State:** Kentucky

**Zip:** 40509

**Location 34:**

**City:** Portland

**Country:** United States

**Facility:** Maine Eye Center

**State:** Maine

**Zip:** 04101

**Location 35:**

**City:** Towson

**Country:** United States

**Facility:** Retina Specialists

**State:** Maryland

**Zip:** 21204

**Location 36:**

**City:** Boston

**Country:** United States

**Facility:** Tufts Medical Center Research

**State:** Massachusetts

**Zip:** 02111

**Location 37:**

**City:** Boston

**Country:** United States

**Facility:** Ophthalmic Consultants of Boston

**State:** Massachusetts

**Zip:** 02114

**Location 38:**

**City:** Worcester

**Country:** United States

**Facility:** Vitreo-Retinal Associates, PC

**State:** Massachusetts

**Zip:** 01605

**Location 39:**

**City:** Grand Rapids

**Country:** United States

**Facility:** Vitreo-Retinal Associates

**State:** Michigan

**Zip:** 49546

**Location 40:**

**City:** Jackson

**Country:** United States

**Facility:** Specialty Eye Institute

**State:** Michigan

**Zip:** 49202

**Location 41:**

**City:** Royal Oak

**Country:** United States

**Facility:** Assoc Retinal Consultants PC

**State:** Michigan

**Zip:** 48073

**Location 42:**

**City:** Southfield

**Country:** United States

**Facility:** Retina Consultants of Michigan

**State:** Michigan

**Zip:** 48034

**Location 43:**

**City:** Lincoln

**Country:** United States

**Facility:** Eye Surgical Associates

**State:** Nebraska

**Zip:** 68506

**Location 44:**

**City:** Las Vegas

**Country:** United States

**Facility:** Retina Consultants of Nevada

**State:** Nevada

**Zip:** 89123

**Location 45:**

**City:** Bloomfield

**Country:** United States

**Facility:** Retina Center of New Jersey

**State:** New Jersey

**Zip:** 07003

**Location 46:**

**City:** Edison

**Country:** United States

**Facility:** New Jersey Retina Research Foundation

**State:** New Jersey

**Zip:** 08820

**Location 47:**

**City:** Lawrenceville

**Country:** United States

**Facility:** Delaware Valley Retina Assoc

**State:** New Jersey

**Zip:** 08648

**Location 48:**

**City:** Hauppauge

**Country:** United States

**Facility:** Long Is. Vitreoretinal Consult

**State:** New York

**Zip:** 11788

**Location 49:**

**City:** Lynbrook

**Country:** United States

**Facility:** Opthalmic Consultants of LI

**State:** New York

**Zip:** 11563

**Location 50:**

**City:** New York

**Country:** United States

**Facility:** New York Eye & Ear Infirmary

**State:** New York

**Zip:** 10003

**Location 51:**

**City:** Orchard Park

**Country:** United States

**Facility:** Retina Consultants of Western New York

**State:** New York

**Zip:** 14127

**Location 52:**

**City:** Syracuse

**Country:** United States

**Facility:** Retina Vit Surgeons/Central NY

**State:** New York

**Zip:** 13224

**Location 53:**

**City:** Asheville

**Country:** United States

**Facility:** Western Carolina Retinal Associate PA

**State:** North Carolina

**Zip:** 28803

**Location 54:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Wake Forest Baptist Health Eye Centre

**State:** North Carolina

**Zip:** 27157

**Location 55:**

**City:** Beachwood

**Country:** United States

**Facility:** Retina Assoc of Cleveland Inc

**State:** Ohio

**Zip:** 44122

**Location 56:**

**City:** Cleveland

**Country:** United States

**Facility:** Cleveland Clinic Foundation; Cole Eye Institute

**State:** Ohio

**Zip:** 44195

**Location 57:**

**City:** Monroeville

**Country:** United States

**Facility:** Retina Vitreous Consultants

**State:** Pennsylvania

**Zip:** 15146

**Location 58:**

**City:** West Mifflin

**Country:** United States

**Facility:** Associates in Ophthalmology

**State:** Pennsylvania

**Zip:** 15122

**Location 59:**

**City:** Ladson

**Country:** United States

**Facility:** Charleston Neuroscience Inst

**State:** South Carolina

**Zip:** 29456

**Location 60:**

**City:** Nashville

**Country:** United States

**Facility:** Tennessee Retina PC.

**State:** Tennessee

**Zip:** 37203

**Location 61:**

**City:** Nashville

**Country:** United States

**Facility:** Vanderbilt

**State:** Tennessee

**Zip:** 37232

**Location 62:**

**City:** Abilene

**Country:** United States

**Facility:** Retina Res Institute of Texas

**State:** Texas

**Zip:** 79606

**Location 63:**

**City:** Arlington

**Country:** United States

**Facility:** Texas Retina Associates

**State:** Texas

**Zip:** 76012

**Location 64:**

**City:** Austin

**Country:** United States

**Facility:** Austin Retina Associates

**State:** Texas

**Zip:** 78705

**Location 65:**

**City:** Austin

**Country:** United States

**Facility:** Retina Research Center

**State:** Texas

**Zip:** 78705

**Location 66:**

**City:** Dallas

**Country:** United States

**Facility:** UT Southwestern MC at Dallas

**State:** Texas

**Zip:** 75390

**Location 67:**

**City:** McAllen

**Country:** United States

**Facility:** Valley Retina Institute P.A.

**State:** Texas

**Zip:** 78503

**Location 68:**

**City:** Willow Park

**Country:** United States

**Facility:** Strategic Clinical Research Group, LLC

**State:** Texas

**Zip:** 76087

**Location 69:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Retina Associates of Utah

**State:** Utah

**Zip:** 84107

**Location 70:**

**City:** Richmond

**Country:** United States

**Facility:** Eye Surgeons of Richmond Inc. dba Virginia Eye Institute

**State:** Virginia

**Zip:** 23226

**Location 71:**

**City:** Richmond

**Country:** United States

**Facility:** Retina Institute of Virginia

**State:** Virginia

**Zip:** 23235

**Location 72:**

**City:** Warrenton

**Country:** United States

**Facility:** Virginia Retina Center

**State:** Virginia

**Zip:** 20186

**Location 73:**

**City:** Silverdale

**Country:** United States

**Facility:** Retina Center Northwest

**State:** Washington

**Zip:** 98383

**Location 74:**

**City:** Spokane

**Country:** United States

**Facility:** Spokane Eye Clinical Research

**State:** Washington

**Zip:** 99204

**Location 75:**

**City:** Morgantown

**Country:** United States

**Facility:** West Virginia University Eye Institute

**State:** West Virginia

**Zip:** 26506

**Location 76:**

**City:** Madison

**Country:** United States

**Facility:** University of Wisconsin

**State:** Wisconsin

**Zip:** 53792

**Location 77:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** Organizacion Medica de Investigacion

**Zip:** C1015ABO

**Location 78:**

**City:** Caba

**Country:** Argentina

**Facility:** Fundacion Zambrano

**Zip:** 1023

**Location 79:**

**City:** Mendoza

**Country:** Argentina

**Facility:** Oftar

**Zip:** M5500GGK

**Location 80:**

**City:** Rosario

**Country:** Argentina

**Facility:** Microcirugía Ocular S.A

**Zip:** S2000CTC

**Location 81:**

**City:** Rosario

**Country:** Argentina

**Facility:** Grupo Laser Vision

**Zip:** S2000DLA

**Location 82:**

**City:** Albury

**Country:** Australia

**Facility:** Eyeclinic Albury Wodonga

**State:** New South Wales

**Zip:** 2640

**Location 83:**

**City:** Parramatta

**Country:** Australia

**Facility:** Marsden Eye Research Centre

**State:** New South Wales

**Zip:** 2150

**Location 84:**

**City:** Sydney

**Country:** Australia

**Facility:** Save Sight Institute

**State:** New South Wales

**Zip:** 2000

**Location 85:**

**City:** Westmead

**Country:** Australia

**Facility:** Sydney West Retina

**State:** New South Wales

**Zip:** 2145

**Location 86:**

**City:** Linz

**Country:** Austria

**Facility:** Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

**Zip:** 4021

**Location 87:**

**City:** Bruxelles

**Country:** Belgium

**Facility:** CHU Brugmann (Victor Horta)

**Zip:** 1020

**Location 88:**

**City:** Gent

**Country:** Belgium

**Facility:** UZ Gent

**Zip:** 9000

**Location 89:**

**City:** Leuven

**Country:** Belgium

**Facility:** UZ Leuven Sint Rafael

**Zip:** 3000

**Location 90:**

**City:** Liège

**Country:** Belgium

**Facility:** CHU Sart-Tilman

**Zip:** 4000

**Location 91:**

**City:** Calgary

**Country:** Canada

**Facility:** Calgary Retina Consultants

**State:** Alberta

**Zip:** T2J 0C8

**Location 92:**

**City:** Vancouver

**Country:** Canada

**Facility:** University of British Columbia

**State:** British Columbia

**Zip:** V6T 1Z4

**Location 93:**

**City:** Halifax

**Country:** Canada

**Facility:** QEII - HSC Department of Ophthalmology

**State:** Nova Scotia

**Zip:** B3H 2Y9

**Location 94:**

**City:** Ottawa

**Country:** Canada

**Facility:** University of Ottawa Eye Institute

**State:** Ontario

**Zip:** K1H 8L6

**Location 95:**

**City:** Toronto

**Country:** Canada

**Facility:** Sunnybrook Health Sciences Centre

**State:** Ontario

**Zip:** M4N 3M5

**Location 96:**

**City:** Toronto

**Country:** Canada

**Facility:** St. Michael'S Hospital

**State:** Ontario

**Zip:** M5G 2C4

**Location 97:**

**City:** Toronto

**Country:** Canada

**Facility:** University Health Network Toronto Western Hospital

**State:** Ontario

**Zip:** M5T 2S8

**Location 98:**

**City:** Boisbriand

**Country:** Canada

**Facility:** Institut De L'Oeil Des Laurentides

**State:** Quebec

**Zip:** J7H 1S6

**Location 99:**

**City:** Roskilde

**Country:** Denmark

**Facility:** Sjællands Universitetshospital, Roskilde; Øjenafdelingen

**Zip:** 4000

**Location 100:**

**City:** Creteil

**Country:** France

**Facility:** Chi De Creteil; Ophtalmologie

**Zip:** 94010

**Location 101:**

**City:** Paris

**Country:** France

**Facility:** Centre Odeon; Exploration Ophtalmologique

**Zip:** 75006

**Location 102:**

**City:** Paris

**Country:** France

**Facility:** Hopital Lariboisiere; Ophtalmologie

**Zip:** 75010

**Location 103:**

**City:** Paris

**Country:** France

**Facility:** Centre Ophtalmologique; Imagerie et laser

**Zip:** 75015

**Location 104:**

**City:** Paris

**Country:** France

**Facility:** Ch Pitie Salpetriere; Ophtalmologie

**Zip:** 75651

**Location 105:**

**City:** Poitiers

**Country:** France

**Facility:** CHU Poitiers - CHR La Miletrie; Ophtalmologie

**Zip:** 86021

**Location 106:**

**City:** Bonn

**Country:** Germany

**Facility:** Universitäts-Augenklinik Bonn

**Zip:** 53127

**Location 107:**

**City:** Göttingen

**Country:** Germany

**Facility:** Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde

**Zip:** 37075

**Location 108:**

**City:** Hannover

**Country:** Germany

**Facility:** Medizinische Hochschule Hannover, Klinik für Augenheilkunde

**Zip:** 30625

**Location 109:**

**City:** Köln

**Country:** Germany

**Facility:** Universitätsklinikum Köln; Augenklinik

**Zip:** 50937

**Location 110:**

**City:** Lübeck

**Country:** Germany

**Facility:** Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde

**Zip:** 23538

**Location 111:**

**City:** Münster

**Country:** Germany

**Facility:** Augenabteilung am St. Franziskus-Hospital

**Zip:** 48145

**Location 112:**

**City:** Münster

**Country:** Germany

**Facility:** Universitätsklinikum Münster; Augenheilkunde

**Zip:** 48149

**Location 113:**

**City:** Budapest

**Country:** Hungary

**Facility:** Budapest Retina Associates Kft.

**Zip:** 1133

**Location 114:**

**City:** Debrecem

**Country:** Hungary

**Facility:** Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

**Zip:** 4032

**Location 115:**

**City:** Pecs

**Country:** Hungary

**Facility:** Ganglion Medial Center

**Zip:** 7621

**Location 116:**

**City:** Roma

**Country:** Italy

**Facility:** Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

**State:** Lazio

**Zip:** 00133

**Location 117:**

**City:** Roma

**Country:** Italy

**Facility:** Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

**State:** Lazio

**Zip:** 00198

**Location 118:**

**City:** Milano

**Country:** Italy

**Facility:** Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

**State:** Lombardia

**Zip:** 20100

**Location 119:**

**City:** Sassari

**Country:** Italy

**Facility:** Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica

**State:** Sardegna

**Zip:** 07100

**Location 120:**

**City:** Mexico, D.F.

**Country:** Mexico

**Facility:** Macula Retina Consultores

**Zip:** 01120

**Location 121:**

**City:** Mexico, D.F.

**Country:** Mexico

**Facility:** Hospital de la Ceguera APEC

**Zip:** 04030

**Location 122:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Academisch Medisch Centrum Universiteit Amsterdam

**Zip:** 1105 AZ

**Location 123:**

**City:** Leiden

**Country:** Netherlands

**Facility:** Leids Universitair Medisch Centrum

**Zip:** 2333 ZA0

**Location 124:**

**City:** Nijmegen

**Country:** Netherlands

**Facility:** Radboud University Nijmegen Medical Centre; Ophthalmology

**Zip:** 6525 EX

**Location 125:**

**City:** Lima

**Country:** Peru

**Facility:** CLINICA RICARDO PALMA; Oftalmologos Contreras

**Zip:** 27

**Location 126:**

**City:** Lima

**Country:** Peru

**Facility:** Clinica Anglo Americana

**Zip:** Lima 27

**Location 127:**

**City:** Bydgoszcz

**Country:** Poland

**Facility:** OFTALMIKA Sp. z o.o

**Zip:** 85-631

**Location 128:**

**City:** Gdańsk

**Country:** Poland

**Facility:** Optimum Profesorskie Centrum Okulistyki

**Zip:** 80-809

**Location 129:**

**City:** Katowice

**Country:** Poland

**Facility:** Gabinet Okulistyczny Prof Edward Wylegala

**Zip:** 40-594

**Location 130:**

**City:** Krakow

**Country:** Poland

**Facility:** SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

**Zip:** 31-501

**Location 131:**

**City:** Bratislava

**Country:** Slovakia

**Facility:** Nemocnica sv. Michala, a.s.

**Zip:** 81108

**Location 132:**

**City:** Trencin

**Country:** Slovakia

**Facility:** Fakultna nemocnica Trencin Ocna klinika

**Zip:** 911 71

**Location 133:**

**City:** Zilina

**Country:** Slovakia

**Facility:** Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

**Zip:** 012 07

**Location 134:**

**City:** Hospitalet De Llobregat

**Country:** Spain

**Facility:** Hospital Universitari de Bellvitge; Servicio de Oftalmologia

**State:** Barcelona

**Zip:** 8907

**Location 135:**

**City:** San Cugat Del Valles

**Country:** Spain

**Facility:** Hospital General de Catalunya

**State:** Barcelona

**Zip:** 08195

**Location 136:**

**City:** Bilbao

**Country:** Spain

**Facility:** Instituto Clinico Quirurgico de Oftalmologia - ICQO

**State:** Guipuzcoa

**Zip:** 48006

**Location 137:**

**City:** Alicante

**Country:** Spain

**Facility:** VISSUM Instituto Oftalmológico de Alicante

**Zip:** 03016

**Location 138:**

**City:** Barcelona

**Country:** Spain

**Facility:** Institut de la Macula i la retina

**Zip:** 08022

**Location 139:**

**City:** Valencia

**Country:** Spain

**Facility:** FISABIO. Fundación Oftalmologica del Mediterraneo

**Zip:** 46015

**Location 140:**

**City:** Valladolid

**Country:** Spain

**Facility:** Hospital Universitario Rio Hortega; Servicio de Oftalmologia

**Zip:** 47012

**Location 141:**

**City:** Zürich

**Country:** Switzerland

**Facility:** Stadtspital Triemli; Augenklinik

**Zip:** 8063

**Location 142:**

**City:** AYR

**Country:** United Kingdom

**Facility:** Ayr Hospital

**Zip:** KA6 6DX

**Location 143:**

**City:** Edinburgh

**Country:** United Kingdom

**Facility:** The Princess Alexandra Eye Pavilion

**Zip:** EH3 9HA

**Location 144:**

**City:** Frimley

**Country:** United Kingdom

**Facility:** Frimley Park Hospital

**Zip:** GU16 7UJ

**Location 145:**

**City:** Sheffield

**Country:** United Kingdom

**Facility:** Royal Hallamshire Hospita

**Zip:** S10 2JF

#### Overall Officials

**Official 1:**

**Affiliation:** Hoffmann-La Roche

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.

**PMID:** 33383315

**Citation:** Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.

**PMID:** 32199866

**Citation:** Holz FG, Sadda SR, Busbee B, Chew EY, Mitchell P, Tufail A, Brittain C, Ferrara D, Gray S, Honigberg L, Martin J, Tong B, Ehrlich JS, Bressler NM; Chroma and Spectri Study Investigators. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration: Chroma and Spectri Phase 3 Randomized Clinical Trials. JAMA Ophthalmol. 2018 Jun 1;136(6):666-677. doi: 10.1001/jamaophthalmol.2018.1544.

**PMID:** 29801123

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-10-02

- Filename: SAP_000.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 809247

- Type Abbrev: SAP

- Upload Date: 2019-01-22T09:48

- Date: 2015-09-24

- Filename: Prot_001.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 3510852

- Type Abbrev: Prot

- Upload Date: 2019-01-22T09:48

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012162

- Term: Retinal Degeneration

- ID: D000012164

- Term: Retinal Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M4589

- Name: Atrophy

- Relevance: HIGH

- As Found: Atrophy

- ID: M11260

- Name: Macular Degeneration

- Relevance: HIGH

- As Found: Age-related Macular Degeneration

- ID: M28712

- Name: Geographic Atrophy

- Relevance: HIGH

- As Found: Geographic Atrophy

- ID: M14997

- Name: Retinal Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008268

- Term: Macular Degeneration

- ID: D000057092

- Term: Geographic Atrophy

- ID: D000001284

- Term: Atrophy

### Misc Info Module

#### Removed Countries

- Country: Brazil

- Country: Portugal

- Country: Russian Federation

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Safety population included all participants who received at least one dose of study drug.

#### Event Groups

**Group ID:** EG000

**Title:** Sham Comparator

**Deaths Num Affected:** 6

**Deaths Num At Risk:** 300

**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.

**ID:** EG000

**Other Num Affected:** 221

**Other Num at Risk:** 300

**Serious Number Affected:** 97

**Serious Number At Risk:** 300

**Title:** Sham Comparator

**Group ID:** EG001

**Title:** Lampalizumab Q4W

**Deaths Num Affected:** 5

**Deaths Num At Risk:** 298

**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.

**ID:** EG001

**Other Num Affected:** 239

**Other Num at Risk:** 298

**Serious Number Affected:** 118

**Serious Number At Risk:** 298

**Title:** Lampalizumab Q4W

**Group ID:** EG002

**Title:** Lampalizumab Q6W

**Deaths Num Affected:** 6

**Deaths Num At Risk:** 303

**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.

**ID:** EG002

**Other Num Affected:** 232

**Other Num at Risk:** 303

**Serious Number Affected:** 108

**Serious Number At Risk:** 303

**Title:** Lampalizumab Q6W

**Frequency Threshold:** 5

#### Other Events

**Term:** Conjunctival haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Eye pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Vitreous floaters

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Vitreous detachment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Dry eye

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Cataract

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Posterior capsule opacification

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Intraocular pressure increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Retinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Punctate keratitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 3

**Num At Risk:** 303

**Term:** Angina pectoris

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Angina unstable

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Arrhythmia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Arteriosclerosis coronary artery

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 3

**Num At Risk:** 303

**Term:** Atrial flutter

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Atrioventricular block first degree

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Bradycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Cardiac arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Cardiac failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Cardiac failure congestive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 6

**Num At Risk:** 303

**Term:** Coronary artery disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Myocardial ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Ventricular fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Colitis ischaemic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Diverticular hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Diverticulum intestinal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Duodenal ulcer haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Enterocolitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Flatulence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Gastric ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Gastric volvulus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Gastroduodenitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Inguinal hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Oesophagitis ulcerative

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Rectal ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Small intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Upper gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** General physical health deterioration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Impaired healing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Bile duct stone

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Cholangitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Cholecystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Abdominal sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Campylobacter infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Cystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Device related infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Diverticulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Endocarditis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Infectious pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Perihepatic abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 11

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 5

**Num At Risk:** 303

**Term:** Pyelonephritis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Staphylococcal sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Viral upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Accidental overdose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Acetabulum fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Ankle fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Comminuted fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Craniocerebral injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Dislocation of vertebra

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 4

**Num At Risk:** 303

**Term:** Femur fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Fibula fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Forearm fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Hip fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 3

**Num At Risk:** 303

**Term:** Humerus fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Internal injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Lower limb fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Lumbar vertebral fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Muscle rupture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Pelvic fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Post procedural haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Radius fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Rib fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Road traffic accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Spinal compression fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Spinal fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Sternal fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Subdural haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Upper limb fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Blood pressure increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Heart rate irregular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Myocardial necrosis marker increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Prostatic specific antigen increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Troponin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Gout

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Hypoglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Iron deficiency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Malnutrition

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Arthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Haemarthrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Intervertebral disc protrusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Neuropathic arthropathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Rotator cuff syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Spinal column stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Benign neoplasm of ureter

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Bladder cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Breast cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Bronchial carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Cholangiocarcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Endometrial cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Lung adenocarcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Lung cancer metastatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Lung neoplasm malignant

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Malignant melanoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Malignant melanoma stage IV

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Malignant pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Meningioma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Myelodysplastic syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Myxofibrosarcoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Neoplasm skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Neuroendocrine carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Non-small cell lung cancer metastatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Oesophageal carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Ovarian cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Ovarian cancer metastatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Pancreatic carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Plasma cell myeloma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Prostate cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Prostate cancer metastatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Skin cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Squamous cell carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Amyotrophic lateral sclerosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Carotid artery stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Cerebral haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Cerebral infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Cerebral microangiopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Cerebrovascular accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Cervicogenic vertigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Dementia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Dementia Alzheimer's type

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Dural arteriovenous fistula

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Epilepsy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Generalised tonic-clonic seizure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Haemorrhagic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Hemiparesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Ischaemic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Lacunar infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Lumbar radiculopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Paraesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Presyncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Seizure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Senile dementia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Transient ischaemic attack

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Vertigo CNS origin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Mental status changes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Acute kidney injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Bladder cyst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Chronic kidney disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Dysuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Haematuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Hydronephrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Nephrolithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Oliguria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Renal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Renal impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Tubulointerstitial nephritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Urinary bladder polyp

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Urinary retention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Acute pulmonary oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Acute respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Bronchial hyperreactivity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Chronic obstructive pulmonary disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 5

**Num At Risk:** 303

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Epiglottic cyst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Haemoptysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Hypoxia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Pneumonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Pneumothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Pneumothorax spontaneous

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Pulmonary air leakage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Skin ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Cardiac pacemaker battery replacement

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Aortic stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Blood pressure inadequately controlled

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Deep vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** May-Thurner syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Peripheral arterial occlusive disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Peripheral embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Thrombophlebitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Spinal osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Spinal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Blindness transient

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Vertigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Borderline glaucoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Choroidal neovascularisation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Iritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Neovascular age-related macular degeneration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 3

**Num At Risk:** 303

**Term:** Open angle glaucoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Retinal artery occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Retinal detachment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Retinal neovascularisation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Retinal tear

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Visual acuity reduced

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 10

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 12

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 8

**Num At Risk:** 303

**Term:** Visual acuity reduced transiently

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Vitreous haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Vitritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Conjunctivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Endophthalmitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Corneal abrasion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Facial bones fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Hyphaema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Intraocular pressure increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 16

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 14

**Num At Risk:** 303

**Term:** Atrial septal defect

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Congenital, familial and genetic disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Postmenopausal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Uterovaginal prolapse

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Haemorrhagic anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Dry age-related macular degeneration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 303

**Term:** Cataract

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Gastrointestinal angiectasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Obstructive pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Cervical vertebral fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Foreign body in eye

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Traumatic intracranial haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Bladder neoplasm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Lipoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Urethral cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Aphasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 303

**Term:** Cognitive disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Embolic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Term:** Orthostatic hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA, version 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 300

**Group ID:** EG001

**Num At Risk:** 298

**Group ID:** EG002

**Num At Risk:** 303

**Time Frame:** Up to approximately 2 years

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 305

**Group ID:** BG001

**Value:** 298

**Group ID:** BG002

**Value:** 303

**Group ID:** BG003

**Value:** 906

**Units:** Participants

### Group

**ID:** BG000

**Title:** Sham Comparator

**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.

### Group

**ID:** BG001

**Title:** Lampalizumab Q4W

**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.

### Group

**ID:** BG002

**Title:** Lampalizumab Q6W

**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 7.8

**Value:** 78.5

#### Measurement

**Group ID:** BG001

**Spread:** 7.9

**Value:** 77.5

#### Measurement

**Group ID:** BG002

**Spread:** 8.5

**Value:** 78.3

#### Measurement

**Group ID:** BG003

**Spread:** 8.1

**Value:** 78.1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 305

**Group ID:** BG001

**Value:** 298

**Group ID:** BG002

**Value:** 303

**Group ID:** BG003

**Value:** 906

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 186

#### Measurement

**Group ID:** BG001

**Value:** 182

#### Measurement

**Group ID:** BG002

**Value:** 185

#### Measurement

**Group ID:** BG003

**Value:** 553

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 119

#### Measurement

**Group ID:** BG001

**Value:** 116

#### Measurement

**Group ID:** BG002

**Value:** 118

#### Measurement

**Group ID:** BG003

**Value:** 353

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 305

**Group ID:** BG001

**Value:** 298

**Group ID:** BG002

**Value:** 303

**Group ID:** BG003

**Value:** 906

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** Native Hawaiian or other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 302

#### Measurement

**Group ID:** BG001

**Value:** 294

#### Measurement

**Group ID:** BG002

**Value:** 295

#### Measurement

**Group ID:** BG003

**Value:** 891

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** Multiple

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 11

**Category Title:** Unknown

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 305

**Group ID:** BG001

**Value:** 298

**Group ID:** BG002

**Value:** 303

**Group ID:** BG003

**Value:** 906

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 18

#### Measurement

**Group ID:** BG003

**Value:** 55

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 279

#### Measurement

**Group ID:** BG001

**Value:** 278

#### Measurement

**Group ID:** BG002

**Value:** 282

#### Measurement

**Group ID:** BG003

**Value:** 839

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 6

**Category Title:** Not Stated

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 6

**Category Title:** Unknown

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 305

**Group ID:** BG001

**Value:** 298

**Group ID:** BG002

**Value:** 303

**Group ID:** BG003

**Value:** 906

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.925

**Value:** 7.953

#### Measurement

**Group ID:** BG001

**Spread:** 3.887

**Value:** 7.910

#### Measurement

**Group ID:** BG002

**Spread:** 4.236

**Value:** 8.116

#### Measurement

**Group ID:** BG003

**Spread:** 4.016

**Value:** 7.993

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 305

**Group ID:** BG001

**Value:** 298

**Group ID:** BG002

**Value:** 302

**Group ID:** BG003

**Value:** 905

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 16.8

**Value:** 29.1

#### Measurement

**Group ID:** BG001

**Spread:** 13.4

**Value:** 25.2

#### Measurement

**Group ID:** BG002

**Spread:** 13.4

**Value:** 20.5

#### Measurement

**Group ID:** BG003

**Spread:** 15.1

**Value:** 25.1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 44

**Group ID:** BG001

**Value:** 33

**Group ID:** BG002

**Value:** 39

**Group ID:** BG003

**Value:** 116

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.37

**Value:** 5.40

#### Measurement

**Group ID:** BG001

**Spread:** 4.02

**Value:** 6.37

#### Measurement

**Group ID:** BG002

**Spread:** 3.40

**Value:** 7.38

#### Measurement

**Group ID:** BG003

**Spread:** 3.64

**Value:** 6.34

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 44

**Group ID:** BG001

**Value:** 33

**Group ID:** BG002

**Value:** 39

**Group ID:** BG003

**Value:** 116

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.9

**Value:** 65.9

#### Measurement

**Group ID:** BG001

**Spread:** 10.0

**Value:** 66.1

#### Measurement

**Group ID:** BG002

**Spread:** 10.1

**Value:** 66.4

#### Measurement

**Group ID:** BG003

**Spread:** 10.0

**Value:** 66.2

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 301

**Group ID:** BG001

**Value:** 295

**Group ID:** BG002

**Value:** 301

**Group ID:** BG003

**Value:** 897

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 15.7

**Value:** 36.0

#### Measurement

**Group ID:** BG001

**Spread:** 17.8

**Value:** 36.9

#### Measurement

**Group ID:** BG002

**Spread:** 16.7

**Value:** 36.2

#### Measurement

**Group ID:** BG003

**Spread:** 16.7

**Value:** 36.4

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 299

**Group ID:** BG001

**Value:** 287

**Group ID:** BG002

**Value:** 293

**Group ID:** BG003

**Value:** 879

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 57.98

**Value:** 106.89

#### Measurement

**Group ID:** BG001

**Spread:** 60.14

**Value:** 109.18

#### Measurement

**Group ID:** BG002

**Spread:** 62.37

**Value:** 104.22

#### Measurement

**Group ID:** BG003

**Spread:** 60.12

**Value:** 106.74

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 278

**Group ID:** BG001

**Value:** 262

**Group ID:** BG002

**Value:** 269

**Group ID:** BG003

**Value:** 809

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 17.33

**Value:** 66.16

#### Measurement

**Group ID:** BG001

**Spread:** 16.12

**Value:** 64.80

#### Measurement

**Group ID:** BG002

**Spread:** 17.27

**Value:** 65.19

#### Measurement

**Group ID:** BG003

**Spread:** 16.91

**Value:** 65.38

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 276

**Group ID:** BG001

**Value:** 275

**Group ID:** BG002

**Value:** 282

**Group ID:** BG003

**Value:** 833

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.83

**Value:** 2.69

#### Measurement

**Group ID:** BG001

**Spread:** 0.79

**Value:** 2.71

#### Measurement

**Group ID:** BG002

**Spread:** 0.82

**Value:** 2.70

#### Measurement

**Group ID:** BG003

**Spread:** 0.81

**Value:** 2.70

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 276

**Group ID:** BG001

**Value:** 273

**Group ID:** BG002

**Value:** 280

**Group ID:** BG003

**Value:** 829

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 20.98

**Value:** 54.98

#### Measurement

**Group ID:** BG001

**Spread:** 20.56

**Value:** 53.78

#### Measurement

**Group ID:** BG002

**Spread:** 22.21

**Value:** 53.67

#### Measurement

**Group ID:** BG003

**Spread:** 21.25

**Value:** 54.14

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 276

**Group ID:** BG001

**Value:** 275

**Group ID:** BG002

**Value:** 282

**Group ID:** BG003

**Value:** 833

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 21.46

**Value:** 62.86

#### Measurement

**Group ID:** BG001

**Spread:** 20.48

**Value:** 60.97

#### Measurement

**Group ID:** BG002

**Spread:** 22.16

**Value:** 62.10

#### Measurement

**Group ID:** BG003

**Spread:** 21.37

**Value:** 61.98

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 276

**Group ID:** BG001

**Value:** 275

**Group ID:** BG002

**Value:** 282

**Group ID:** BG003

**Value:** 833

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 52.95

**Value:** 80.89

#### Measurement

**Group ID:** BG001

**Spread:** 54.55

**Value:** 85.18

#### Measurement

**Group ID:** BG002

**Spread:** 54.23

**Value:** 79.49

#### Measurement

**Group ID:** BG003

**Spread:** 53.89

**Value:** 81.82

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 278

**Group ID:** BG001

**Value:** 265

**Group ID:** BG002

**Value:** 271

**Group ID:** BG003

**Value:** 814

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.915

**Value:** 8.015

#### Measurement

**Group ID:** BG001

**Spread:** 4.118

**Value:** 8.152

#### Measurement

**Group ID:** BG002

**Spread:** 4.399

**Value:** 8.406

#### Measurement

**Group ID:** BG003

**Spread:** 4.142

**Value:** 8.190

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 181

**Group ID:** BG001

**Value:** 176

**Group ID:** BG002

**Value:** 177

**Group ID:** BG003

**Value:** 534

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.952

**Value:** 7.864

#### Measurement

**Group ID:** BG001

**Spread:** 3.515

**Value:** 7.560

#### Measurement

**Group ID:** BG002

**Spread:** 3.975

**Value:** 7.705

#### Measurement

**Group ID:** BG003

**Spread:** 3.814

**Value:** 7.710

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 124

**Group ID:** BG001

**Value:** 122

**Group ID:** BG002

**Value:** 125

**Group ID:** BG003

**Value:** 371

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 5
**Description:** At baseline the area of GA was assessed by FAF.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF)
**Unit of Measure:** millimeter square (mm^2)
### Measure 6
**Description:** Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization).
**Title:** Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry
**Unit of Measure:** absolute scotomatous points
### Measure 7
**Description:** Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization).
**Title:** Macular Sensitivity as Assessed by Mesopic Microperimetry
**Unit of Measure:** decibel (dB)
### Measure 8
**Description:** BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study
**Unit of Measure:** letters
### Measure 9
**Description:** The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions
**Unit of Measure:** letters
### Measure 10
**Description:** Minnesota Low-Vision Reading (MNRead) acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test or Radner Reading Charts
**Unit of Measure:** words per minute (wpm)
### Measure 11
**Description:** NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score
**Unit of Measure:** score on a scale
### Measure 12
**Description:** The FRI was an interviewer-administered questionnaire with 7-items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** Mean Functional Reading Independence (FRI) Index
**Unit of Measure:** score on a scale
### Measure 13
**Description:** NEI-VFQ-25 questionnaire included 25 items based on near activities, which are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** NEI VFQ-25 Near Activity Subscale Score
**Unit of Measure:** score on a scale
### Measure 14
**Description:** NEI-VFQ-25 questionnaire included 25 items based on which distance activities was measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** NEI VFQ-25 Distance Activity Subscale Score
**Unit of Measure:** score on a scale
### Measure 15
**Description:** MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts
**Unit of Measure:** wpm
### Measure 16
**Description:** For CFI profile, positive biomarker status refers to the presence (carrier) of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** GA Area in Complement Factor I (CFI) Positive Participants
**Unit of Measure:** mm^2
### Measure 17
**Description:** For CFI profile, negative biomarker status refers to the absence of the risk allele at CFI and at least one risk allele at CFH or C2/CFB.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
**Title:** GA Area in CFI Negative Participants
**Unit of Measure:** mm^2
**Population Description:** Intent-to-treat (ITT) population included all the participants who were randomized to the study.
## Results Section - More Information Module
### Certain Agreement
**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.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** This study was terminated early by the Sponsor because the compound had demonstrated to lack of efficacy. Thus, not all participants in this study completed the full duration of treatment.
### Point of Contact
**Email:** genentech@druginfo.com
**Organization:** Hoffmann-La Roche
**Phone:** 800 821 - 8590
**Title:** Medical Communications
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -0.206
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.167
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.8381
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.019
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.134
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.236
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.5901
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.051
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -5.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 4.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.9350
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.2
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -5.0
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.2
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.9789
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.1
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -0.66
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.22
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.5538
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.28
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -1.60
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.35
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.2032
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.63
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -0.7
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.2547
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 1.0
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -1.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.6
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.8423
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.2
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 0.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.2
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.3248
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.3
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.7
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.7209
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.1
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** -1.4
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.6
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.5695
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.6
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -1.7
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.3
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.7865
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.3
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 0.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.7
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.9448
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.0
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.8764
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.0
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** -1.07
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 12.38
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0991
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 5.66
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -7.66
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.69
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.7713
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.99
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** -5.09
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 8.53
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.6204
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 1.72
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -5.31
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 8.25
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.6705
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 1.47
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 10
#### Analysis
**CI Lower Limit:** -2.35
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.64
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.7246
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.36
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -3.53
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.40
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.1193
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -1.56
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** -2.84
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.39
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.8659
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.22
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -4.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.64
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.1399
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -1.94
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 12
#### Analysis
**CI Lower Limit:** -1.79
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.76
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.4855
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.99
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -4.33
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.13
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.2515
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -1.60
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 13
#### Analysis
**CI Lower Limit:** -0.18
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.04
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.2075
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.07
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.19
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.02
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.1222
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.08
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 14
#### Analysis
**CI Lower Limit:** -0.266
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.223
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.8612
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.022
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.165
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.319
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.5317
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.077
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.322
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.257
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.8240
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.033
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.283
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.294
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.9676
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.006
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.066
- **Upper Limit:** 
- **Value:** 2.035
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.068
- **Upper Limit:** 
- **Value:** 2.016
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.067
- **Upper Limit:** 
- **Value:** 2.086
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.7
- **Upper Limit:** 
- **Value:** 8.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.8
- **Upper Limit:** 
- **Value:** 8.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.8
- **Upper Limit:** 
- **Value:** 8.3
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.33
- **Upper Limit:** 
- **Value:** -1.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.34
- **Upper Limit:** 
- **Value:** -1.33
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.35
- **Upper Limit:** 
- **Value:** -2.24
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.6
- **Upper Limit:** 
- **Value:** -4.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.6
- **Upper Limit:** 
- **Value:** -3.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.6
- **Upper Limit:** 
- **Value:** -4.6
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 81.6
- **Spread:** 
- **Upper Limit:** 90.0
- **Value:** 85.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 85.0
- **Spread:** 
- **Upper Limit:** 92.6
- **Value:** 88.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 83.0
- **Spread:** 
- **Upper Limit:** 91.1
- **Value:** 87.0
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.7
- **Upper Limit:** 
- **Value:** -3.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.7
- **Upper Limit:** 
- **Value:** -2.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.7
- **Upper Limit:** 
- **Value:** -2.7
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 82.7
- **Spread:** 
- **Upper Limit:** 90.9
- **Value:** 86.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 80.9
- **Spread:** 
- **Upper Limit:** 89.6
- **Value:** 85.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 82.4
- **Spread:** 
- **Upper Limit:** 90.8
- **Value:** 86.6
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.37
- **Upper Limit:** 
- **Value:** -18.97
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.47
- **Upper Limit:** 
- **Value:** -13.32
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.44
- **Upper Limit:** 
- **Value:** -19.96
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.41
- **Upper Limit:** 
- **Value:** -19.63
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.49
- **Upper Limit:** 
- **Value:** -17.91
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.47
- **Upper Limit:** 
- **Value:** -18.16
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.71
- **Upper Limit:** 
- **Value:** -1.31
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.72
- **Upper Limit:** 
- **Value:** -1.66
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.70
- **Upper Limit:** 
- **Value:** -2.87
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.93
- **Upper Limit:** 
- **Value:** -2.12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.94
- **Upper Limit:** 
- **Value:** -2.35
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.92
- **Upper Limit:** 
- **Value:** -4.06
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.99
- **Upper Limit:** 
- **Value:** -2.03
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.00
- **Upper Limit:** 
- **Value:** -1.04
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.97
- **Upper Limit:** 
- **Value:** -3.62
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.04
- **Upper Limit:** 
- **Value:** -0.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.04
- **Upper Limit:** 
- **Value:** -0.13
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.04
- **Upper Limit:** 
- **Value:** -0.15
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.086
- **Upper Limit:** 
- **Value:** 2.067
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.089
- **Upper Limit:** 
- **Value:** 2.045
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.087
- **Upper Limit:** 
- **Value:** 2.144
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 162
- **Group ID:** OG001
- **Value:** 152
- **Group ID:** OG002
- **Value:** 160
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.103
- **Upper Limit:** 
- **Value:** 2.006
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.105
- **Upper Limit:** 
- **Value:** 1.974
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.104
- **Upper Limit:** 
- **Value:** 2.012
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 112
- **Group ID:** OG001
- **Value:** 107
- **Group ID:** OG002
- **Value:** 110
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in Mixed-effect model repeated measures (MMRM) analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
**Type:** PRIMARY
**Unit of Measure:** millimeter square (mm^2)
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 2
**Description:** Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48
**Type:** SECONDARY
**Unit of Measure:** absolute scotomatous points
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 3
**Description:** Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
**Type:** SECONDARY
**Unit of Measure:** decibel (dB)
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 4
**Description:** BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48
**Type:** SECONDARY
**Unit of Measure:** letters
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 5
**Description:** Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.
**Reporting Status:** POSTED
**Time Frame:** Week 48
**Title:** Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 6
**Description:** The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48
**Type:** SECONDARY
**Unit of Measure:** letters
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 7
**Description:** Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.
**Reporting Status:** POSTED
**Time Frame:** Week 48
**Title:** Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 8
**Description:** MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48
**Type:** SECONDARY
**Unit of Measure:** words per minute (wpm)
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 9
**Description:** MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48
**Type:** SECONDARY
**Unit of Measure:** wpm
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 10
**Description:** NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 11
**Description:** NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 12
**Description:** NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 13
**Description:** The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
#### Outcome Measure 14
**Description:** For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population included all the participants who were randomized to the study. The analysis was done specifically for CFI-positive and negative participants. Number analyzed for each row signifies the participants evaluated for specified categories for each reporting group.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 48
**Title:** Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
**Type:** PRIMARY
**Unit of Measure:** mm^2
##### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** OG000
**Title:** Sham Comparator
##### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** OG001
**Title:** Lampalizumab Q4W
##### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** OG002
**Title:** Lampalizumab Q6W
### Participant Flow Module
#### Group
**Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
**ID:** FG000
**Title:** Sham Comparator
#### Group
**Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
**ID:** FG001
**Title:** Lampalizumab Q4W
#### Group
**Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
**ID:** FG002
**Title:** Lampalizumab Q6W
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 9
###### Reason
**Group ID:** FG002
**Number of Subjects:** 8
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 6
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Non-compliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 25
###### Reason
**Group ID:** FG001
**Number of Subjects:** 29
###### Reason
**Group ID:** FG002
**Number of Subjects:** 24
##### Withdraw
**Type:** Study Terminated by Sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 98
###### Reason
**Group ID:** FG001
**Number of Subjects:** 88
###### Reason
**Group ID:** FG002
**Number of Subjects:** 94
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Unspecified Reason
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 305
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 298
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 303
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 163
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 160
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 165
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 142
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 138
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 138
**Pre-Assignment Details:** This study enrolled participants with bilateral Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) and no signs of prior or active choroidal neovascularization (CNV), age \>= 50 years with a valid complement factor I (CFI)-profile biomarker result.
**Recruitment Details:** A total of 906 participants were randomized to the study from 131 investigation sites across 19 countries. The study was terminated early by the Sponsor due to lack of efficacy.
**Has Results:** True