## Protocol Section
### Identification Module
**NCT ID:** NCT03706079

**Acronym:** DESTINATION

**Brief Title:** Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma

**Official Title:** A Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (DESTINATION)

#### Organization Study ID Info
**ID:** D5180C00018
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2022-05-18

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-06

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-10-26

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-02-09

**Type:** ACTUAL

**Results First Submit Date:** 2022-10-24

**Results First Submit QC Date:** 2023-01-11

#### Start Date
**Date:** 2019-01-07

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2018-10-15
**Type:** ACTUAL
**Study First Submit Date:** 2018-10-11
**Study First Submit QC Date:** 2018-10-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Amgen

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma. The study consists of a treatment phase, followed by a follow-up phase where subjects will not receive IP. The length of the follow up phase is determined by which study the subject had previously completed.

**Detailed Description:** Subjects who have not met investigational product discontinuation criteria and have attended the EOT visit in either study D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Parallel Group, Placebo Controlled, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab versus placebo in Adults and Adolescents (12 years of age and older) with a history of asthma exacerbations and inadequately controlled severe asthma receiving medium or high dose inhaled corticosteroid (ICS) plus at least one additional asthma controller medication with or without oral corticosteroids

Following treatment, subjects will enter a follow-up phase, determined by the predecessor study they had previously completed. Subjects will not receive IP during the follow-up phase. For subjects who entered the study from study D5180C00007 and did not meet IP Discontinuation criteria, the follow-up phase will extend from week 104 to Week 140. Subjects who entered the study from study D5180C00009 will have their follow-up phase extend to week 116.

### Conditions Module

**Conditions:**

- Asthma

**Keywords:**

- Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Subjects previously randomized in one of the predecessor studies to tezepelumab will be assigned and remain on tezepelumab dosing in the Destination Study.

Subjects randomized to placebo arm in the predecessor studies will be re-randomized in a 1:1 ratio to either tezepelumab or placebo.

Given the randomization scheme of subjects in the predecessor studies, this will give an overall subject distribution of 3:1 (tezepelumab:placebo), assuming a similar number of subjects rollover from each arm in the predecessor studies.

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** Double-Blind

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 951

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Tezepelumab subcutaneous injection

**Intervention Names:**

- Biological: Tezepelumab

**Label:** Tezepelumab

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo: Placebo subcutaneous injection

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Tezepelumab

**Description:** Tezepelumab subcutaneous injection

**Name:** Tezepelumab

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo subcutaneous injection

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Includes adverse events with an onset date between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set. Exposure adjusted rates are defined as number of subjects with AEs divided by total time at risk across all subjects, multiplied by 100

**Measure:** Exposure Adjusted Incidence Rates of AEs/SAEs

**Time Frame:** Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.

**Description:** Includes time between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set.

**Measure:** Total Time at Risk

**Time Frame:** Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.

#### Secondary Outcomes

**Description:** The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)

**Measure:** Annualized Asthma Exacerbation Rate (AAER)

**Time Frame:** Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Provision of signed and dated written informed consent
* Negative urine test for female subjects of childbearing potential prior to administration of IP at visit 1
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from screening, and must agree to continue using such precautions for 16 weeks after the final dose of IP.
* Female or male subjects who have not met investigational product discontinuation criteria and have attended the EOT visit in either study D5180C00007 (NAVIGATOR) or D5180C00009 (SOURCE)

To enter the extended follow-up phase of the study, the following inclusion criteria also apply:

* Provision of signed and dated Addendum for Extended Follow-up to informed consent, as well as assent by adolescent subjects where applicable, prior to any mandatory study specific procedures, sampling and analyses before Extended Follow Up.
* Must have entered DESTINATION from D5180C00007 study and have completed IP dosing to Week 100, have not met IP Discontinuation criteria and have attended the EOT Visit.

Exclusion Criteria:

* Any clinically important pulmonary disease other than asthma
* Any disorder, including, but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable
* History of chronic alcohol or drug abuse within 12 months prior to visit 1
* Current malignancy or malignancy that developed during a predecessor study
* Major surgery or planned surgical procedures requiring general anesthesia or inpatient status for \> 1 day during the conduct of the study
* Treatment with systemic immunosuppressive/immunomodulating drugs except for OCS used in the treatment of asthma/asthma exacerbations within the last 12 weeks prior to randomization
* Concurrent enrolment in another clinical study involving an IP
* Any clinically meaningful abnormal finding in physical examination, vital signs, ECG,haematology, clinical chemistry, or urinalysis during the predecessor study
* Pregnant, breastfeeding, or lactating

To enter the extended follow-up phase of the study (which extends from week 104 to week 140), the following exclusion criteria also apply:

* Discontinuation of IP during the treatment period of DESTINATION.
* Entered DESTINATION from D5180C00009 (SOURCE) study.

**Maximum Age:** 81 Years

**Minimum Age:** 13 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Dothan

**Country:** United States

**Facility:** Research Site

**State:** Alabama

**Zip:** 36303

**Location 2:**

**City:** Gilbert

**Country:** United States

**Facility:** Research Site

**State:** Arizona

**Zip:** 85234

**Location 3:**

**City:** Bakersfield

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 93301

**Location 4:**

**City:** Huntington Beach

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 92647

**Location 5:**

**City:** Long Beach

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 90808

**Location 6:**

**City:** Los Angeles

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 90025

**Location 7:**

**City:** Newport Beach

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 92663

**Location 8:**

**City:** Northridge

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 91324

**Location 9:**

**City:** Palm Desert

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 92260

**Location 10:**

**City:** Rolling Hills Estates

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 90274

**Location 11:**

**City:** Walnut Creek

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 94598

**Location 12:**

**City:** Westminster

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 92683

**Location 13:**

**City:** New Haven

**Country:** United States

**Facility:** Research Site

**State:** Connecticut

**Zip:** 06519

**Location 14:**

**City:** Kissimmee

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 34744

**Location 15:**

**City:** Kissimmee

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 34746

**Location 16:**

**City:** Port Charlotte

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 33952

**Location 17:**

**City:** Sarasota

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 34239

**Location 18:**

**City:** Tampa

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 33607

**Location 19:**

**City:** Winter Park

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 32789-4681

**Location 20:**

**City:** Boise

**Country:** United States

**Facility:** Research Site

**State:** Idaho

**Zip:** 83706

**Location 21:**

**City:** Zachary

**Country:** United States

**Facility:** Research Site

**State:** Louisiana

**Zip:** 70791

**Location 22:**

**City:** White Marsh

**Country:** United States

**Facility:** Research Site

**State:** Maryland

**Zip:** 21162

**Location 23:**

**City:** Boston

**Country:** United States

**Facility:** Research Site

**State:** Massachusetts

**Zip:** 02115

**Location 24:**

**City:** Ann Arbor

**Country:** United States

**Facility:** Research Site

**State:** Michigan

**Zip:** 48109

**Location 25:**

**City:** Saint Louis

**Country:** United States

**Facility:** Research Site

**State:** Missouri

**Zip:** 63141

**Location 26:**

**City:** Lincoln

**Country:** United States

**Facility:** Research Site

**State:** Nebraska

**Zip:** 68510

**Location 27:**

**City:** Las Vegas

**Country:** United States

**Facility:** Research Site

**State:** Nevada

**Zip:** 89119

**Location 28:**

**City:** Northfield

**Country:** United States

**Facility:** Research Site

**State:** New Jersey

**Zip:** 08225

**Location 29:**

**City:** Bronx

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 10459

**Location 30:**

**City:** Bronx

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 10461

**Location 31:**

**City:** Brooklyn

**Country:** United States

**Facility:** Research Site

**State:** New York

**Zip:** 11235

**Location 32:**

**City:** Charlotte

**Country:** United States

**Facility:** Research Site

**State:** North Carolina

**Zip:** 28207

**Location 33:**

**City:** Durham

**Country:** United States

**Facility:** Research Site

**State:** North Carolina

**Zip:** 27705

**Location 34:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Research Site

**State:** North Carolina

**Zip:** 27104

**Location 35:**

**City:** Cincinnati

**Country:** United States

**Facility:** Research Site

**State:** Ohio

**Zip:** 45229

**Location 36:**

**City:** Cincinnati

**Country:** United States

**Facility:** Research Site

**State:** Ohio

**Zip:** 45236

**Location 37:**

**City:** Edmond

**Country:** United States

**Facility:** Research Site

**State:** Oklahoma

**Zip:** 73034

**Location 38:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Research Site

**State:** Oklahoma

**Zip:** 73120

**Location 39:**

**City:** Medford

**Country:** United States

**Facility:** Research Site

**State:** Oregon

**Zip:** 97504

**Location 40:**

**City:** Philadelphia

**Country:** United States

**Facility:** Research Site

**State:** Pennsylvania

**Zip:** 19140

**Location 41:**

**City:** Anderson

**Country:** United States

**Facility:** Research Site

**State:** South Carolina

**Zip:** 29621

**Location 42:**

**City:** Columbia

**Country:** United States

**Facility:** Research Site

**State:** South Carolina

**Zip:** 29204

**Location 43:**

**City:** Greenville

**Country:** United States

**Facility:** Research Site

**State:** South Carolina

**Zip:** 29607

**Location 44:**

**City:** Amarillo

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 79109

**Location 45:**

**City:** Boerne

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 78006

**Location 46:**

**City:** McKinney

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 75069

**Location 47:**

**City:** McKinney

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 75071

**Location 48:**

**City:** Plano

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 75093

**Location 49:**

**City:** San Antonio

**Country:** United States

**Facility:** Research Site

**State:** Texas

**Zip:** 78251

**Location 50:**

**City:** Manassas

**Country:** United States

**Facility:** Research Site

**State:** Virginia

**Zip:** 20110

**Location 51:**

**City:** Cudahy

**Country:** United States

**Facility:** Research Site

**State:** Wisconsin

**Zip:** 53110

**Location 52:**

**City:** Madison

**Country:** United States

**Facility:** Research Site

**State:** Wisconsin

**Zip:** 53792

**Location 53:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** Research Site

**Zip:** 1027

**Location 54:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** Research Site

**Zip:** C1414AIF

**Location 55:**

**City:** Caba

**Country:** Argentina

**Facility:** Research Site

**Zip:** C1425BEN

**Location 56:**

**City:** Ciudad de Buenos Aires

**Country:** Argentina

**Facility:** Research Site

**Zip:** 1425

**Location 57:**

**City:** Córdoba

**Country:** Argentina

**Facility:** Research Site

**Zip:** X5003DCE

**Location 58:**

**City:** Mendoza

**Country:** Argentina

**Facility:** Research Site

**Zip:** 5500

**Location 59:**

**City:** Nueve de julio

**Country:** Argentina

**Facility:** Research Site

**Zip:** B6500EZL

**Location 60:**

**City:** Quilmes

**Country:** Argentina

**Facility:** Research Site

**Zip:** B1878FNR

**Location 61:**

**City:** San Fernando

**Country:** Argentina

**Facility:** Research Site

**Zip:** B1646EBJ

**Location 62:**

**City:** San Miguel de Tucuman

**Country:** Argentina

**Facility:** Research Site

**Zip:** T4000IAQ

**Location 63:**

**City:** Kent Town

**Country:** Australia

**Facility:** Research Site

**Zip:** 5067

**Location 64:**

**City:** Melbourne

**Country:** Australia

**Facility:** Research Site

**Zip:** 3004

**Location 65:**

**City:** New Lambton

**Country:** Australia

**Facility:** Research Site

**Zip:** 2310

**Location 66:**

**City:** Spearwood

**Country:** Australia

**Facility:** Research Site

**Zip:** 6163

**Location 67:**

**City:** Westmead

**Country:** Australia

**Facility:** Research Site

**Zip:** 2145

**Location 68:**

**City:** Woolloongabba

**Country:** Australia

**Facility:** Research Site

**Zip:** 4102

**Location 69:**

**City:** Wien

**Country:** Austria

**Facility:** Research Site

**Zip:** 1090

**Location 70:**

**City:** Wien

**Country:** Austria

**Facility:** Research Site

**Zip:** 1130

**Location 71:**

**City:** Blumenau

**Country:** Brazil

**Facility:** Research Site

**Zip:** 89030-101

**Location 72:**

**City:** Botucatu

**Country:** Brazil

**Facility:** Research Site

**Zip:** 18618-970

**Location 73:**

**City:** Curitiba

**Country:** Brazil

**Facility:** Research Site

**Zip:** 80060-900

**Location 74:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Research Site

**Zip:** 9002-060

**Location 75:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Research Site

**Zip:** 90020-090

**Location 76:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Research Site

**Zip:** 90610-000

**Location 77:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Research Site

**Zip:** 91350-200

**Location 78:**

**City:** Recife

**Country:** Brazil

**Facility:** Research Site

**Zip:** 50070-550

**Location 79:**

**City:** Salvador

**Country:** Brazil

**Facility:** Research Site

**Zip:** 40060-330

**Location 80:**

**City:** Santo Andre

**Country:** Brazil

**Facility:** Research Site

**Zip:** 09080-110

**Location 81:**

**City:** Sao Bernardo do Campo

**Country:** Brazil

**Facility:** Research Site

**Zip:** 09750-420

**Location 82:**

**City:** Sorocaba

**Country:** Brazil

**Facility:** Research Site

**Zip:** 18040-425

**Location 83:**

**City:** Calgary

**Country:** Canada

**Facility:** Research Site

**State:** Alberta

**Zip:** T2N 4Z6

**Location 84:**

**City:** Sherwood Park

**Country:** Canada

**Facility:** Research Site

**State:** Alberta

**Zip:** T8L 0N2

**Location 85:**

**City:** Ajax

**Country:** Canada

**Facility:** Research Site

**State:** Ontario

**Zip:** L1S 2J5

**Location 86:**

**City:** Mississauga

**Country:** Canada

**Facility:** Research Site

**State:** Ontario

**Zip:** L5A 3V4

**Location 87:**

**City:** Ottawa

**Country:** Canada

**Facility:** Research Site

**State:** Ontario

**Zip:** K1H 1E4

**Location 88:**

**City:** Windsor

**Country:** Canada

**Facility:** Research Site

**State:** Ontario

**Zip:** N8X 1T3

**Location 89:**

**City:** Montreal

**Country:** Canada

**Facility:** Research Site

**State:** Quebec

**Zip:** H4J 1C5

**Location 90:**

**City:** St Charles Borromee

**Country:** Canada

**Facility:** Research Site

**State:** Quebec

**Zip:** J6E 2B4

**Location 91:**

**City:** Trois-Rivières

**Country:** Canada

**Facility:** Research Site

**State:** Quebec

**Zip:** G8T 7A1

**Location 92:**

**City:** Quebec

**Country:** Canada

**Facility:** Research Site

**Zip:** G1G 3Y8

**Location 93:**

**City:** Brest Cedex 2

**Country:** France

**Facility:** Research Site

**Zip:** 29609

**Location 94:**

**City:** Le Kremlin-Bicêtre

**Country:** France

**Facility:** Research Site

**Zip:** 94270

**Location 95:**

**City:** Lyon Cedex 04

**Country:** France

**Facility:** Research Site

**Zip:** 69317

**Location 96:**

**City:** Marseille Cedex 20

**Country:** France

**Facility:** Research Site

**Zip:** 13915

**Location 97:**

**City:** Montpellier

**Country:** France

**Facility:** Research Site

**Zip:** 34090

**Location 98:**

**City:** Nantes

**Country:** France

**Facility:** Research Site

**Zip:** 44093

**Location 99:**

**City:** Paris

**Country:** France

**Facility:** Research Site

**Zip:** 75012

**Location 100:**

**City:** Paris

**Country:** France

**Facility:** Research Site

**Zip:** 75018

**Location 101:**

**City:** Pessac

**Country:** France

**Facility:** Research Site

**Zip:** 33604

**Location 102:**

**City:** Strasbourg Cedex

**Country:** France

**Facility:** Research Site

**Zip:** 67091

**Location 103:**

**City:** Bamberg

**Country:** Germany

**Facility:** Research Site

**Zip:** 96049

**Location 104:**

**City:** Berlin

**Country:** Germany

**Facility:** Research Site

**Zip:** 10367

**Location 105:**

**City:** Berlin

**Country:** Germany

**Facility:** Research Site

**Zip:** 10717

**Location 106:**

**City:** Berlin

**Country:** Germany

**Facility:** Research Site

**Zip:** 10969

**Location 107:**

**City:** Frankfurt am Main

**Country:** Germany

**Facility:** Research Site

**Zip:** 60596

**Location 108:**

**City:** Frankfurt

**Country:** Germany

**Facility:** Research Site

**Zip:** 60596

**Location 109:**

**City:** Hamburg

**Country:** Germany

**Facility:** Research Site

**Zip:** 20354

**Location 110:**

**City:** Hamburg

**Country:** Germany

**Facility:** Research Site

**Zip:** 22299

**Location 111:**

**City:** Hannover

**Country:** Germany

**Facility:** Research Site

**Zip:** 30625

**Location 112:**

**City:** Hannover

**Country:** Germany

**Facility:** Research Site

**Zip:** D-30173

**Location 113:**

**City:** Koblenz

**Country:** Germany

**Facility:** Research Site

**Zip:** 56068

**Location 114:**

**City:** Landsberg

**Country:** Germany

**Facility:** Research Site

**Zip:** 86899

**Location 115:**

**City:** Leipzig

**Country:** Germany

**Facility:** Research Site

**Zip:** 04357

**Location 116:**

**City:** Lübeck

**Country:** Germany

**Facility:** Research Site

**Zip:** 23552

**Location 117:**

**City:** Mainz

**Country:** Germany

**Facility:** Research Site

**Zip:** 55131

**Location 118:**

**City:** Ashkelon

**Country:** Israel

**Facility:** Research Site

**Zip:** 7830604

**Location 119:**

**City:** Haifa

**Country:** Israel

**Facility:** Research Site

**Zip:** 34362

**Location 120:**

**City:** Jerusalem

**Country:** Israel

**Facility:** Research Site

**Zip:** 91031

**Location 121:**

**City:** Jerusalem

**Country:** Israel

**Facility:** Research Site

**Zip:** 91120

**Location 122:**

**City:** Kfar Saba

**Country:** Israel

**Facility:** Research Site

**Zip:** 49281

**Location 123:**

**City:** Rehovot

**Country:** Israel

**Facility:** Research Site

**Zip:** 7661041

**Location 124:**

**City:** Bucheon-si

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 420-767

**Location 125:**

**City:** Cheongju-si

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 28644

**Location 126:**

**City:** Daegu

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 41404

**Location 127:**

**City:** Daegu

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 42415

**Location 128:**

**City:** Jeju-do

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 63241

**Location 129:**

**City:** Jeonju-si

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 54907

**Location 130:**

**City:** Seongnam-si

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 13620

**Location 131:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 02447

**Location 132:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 03312

**Location 133:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 03722

**Location 134:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 05505

**Location 135:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 06351

**Location 136:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 06591

**Location 137:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 08308

**Location 138:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 150-713

**Location 139:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 158-710

**Location 140:**

**City:** Suwon-si

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 16499

**Location 141:**

**City:** Kraków

**Country:** Poland

**Facility:** Research Site

**Zip:** 31-559

**Location 142:**

**City:** Wrocław

**Country:** Poland

**Facility:** Research Site

**Zip:** 53-301

**Location 143:**

**City:** Łódź

**Country:** Poland

**Facility:** Research Site

**Zip:** 90-153

**Location 144:**

**City:** Izhevsk

**Country:** Russian Federation

**Facility:** Research Site

**Zip:** 426035

**Location 145:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Research Site

**Zip:** 115093

**Location 146:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Research Site

**Zip:** 115522

**Location 147:**

**City:** St-Petersburg

**Country:** Russian Federation

**Facility:** Research Site

**Zip:** 193231

**Location 148:**

**City:** Jeddah

**Country:** Saudi Arabia

**Facility:** Research Site

**Zip:** 21423

**Location 149:**

**City:** Jeddah

**Country:** Saudi Arabia

**Facility:** Research Site

**Zip:** 22252

**Location 150:**

**City:** Bellville

**Country:** South Africa

**Facility:** Research Site

**Zip:** 7530

**Location 151:**

**City:** Cape Town

**Country:** South Africa

**Facility:** Research Site

**Zip:** 7700

**Location 152:**

**City:** Cape Town

**Country:** South Africa

**Facility:** Research Site

**Zip:** 7764

**Location 153:**

**City:** Durban

**Country:** South Africa

**Facility:** Research Site

**Zip:** 4001

**Location 154:**

**City:** Durban

**Country:** South Africa

**Facility:** Research Site

**Zip:** 4091

**Location 155:**

**City:** Durban

**Country:** South Africa

**Facility:** Research Site

**Zip:** 4092

**Location 156:**

**City:** Durban

**Country:** South Africa

**Facility:** Research Site

**Zip:** 4450

**Location 157:**

**City:** Johannesburg

**Country:** South Africa

**Facility:** Research Site

**Zip:** 1724

**Location 158:**

**City:** Johannesburg

**Country:** South Africa

**Facility:** Research Site

**Zip:** 1829

**Location 159:**

**City:** Johannesburg

**Country:** South Africa

**Facility:** Research Site

**Zip:** 2113

**Location 160:**

**City:** Lenasia Ext8

**Country:** South Africa

**Facility:** Research Site

**Zip:** 1820

**Location 161:**

**City:** Meadowdale, Germiston

**Country:** South Africa

**Facility:** Research Site

**Zip:** 1614

**Location 162:**

**City:** Middelburg

**Country:** South Africa

**Facility:** Research Site

**Zip:** 1055

**Location 163:**

**City:** Parow

**Country:** South Africa

**Facility:** Research Site

**Zip:** 7505

**Location 164:**

**City:** Umkomaas

**Country:** South Africa

**Facility:** Research Site

**Zip:** 4170

**Location 165:**

**City:** Kaohsiung

**Country:** Taiwan

**Facility:** Research Site

**Zip:** 80756

**Location 166:**

**City:** Taichung

**Country:** Taiwan

**Facility:** Research Site

**Zip:** 40447

**Location 167:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Research Site

**Zip:** 235

**Location 168:**

**City:** Ankara

**Country:** Turkey

**Facility:** Research Site

**Zip:** 06230

**Location 169:**

**City:** Ankara

**Country:** Turkey

**Facility:** Research Site

**Zip:** 06280

**Location 170:**

**City:** Bursa

**Country:** Turkey

**Facility:** Research Site

**Zip:** 16059

**Location 171:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Research Site

**Zip:** 34098

**Location 172:**

**City:** Dnipro

**Country:** Ukraine

**Facility:** Research Site

**Zip:** 49007

**Location 173:**

**City:** Ivano-Frankivsk

**Country:** Ukraine

**Facility:** Research Site

**Zip:** 76018

**Location 174:**

**City:** Kharkiv Region

**Country:** Ukraine

**Facility:** Research Site

**Zip:** 61075

**Location 175:**

**City:** Kherson

**Country:** Ukraine

**Facility:** Research Site

**Zip:** 73000

**Location 176:**

**City:** Lutsk

**Country:** Ukraine

**Facility:** Research Site

**Zip:** 43000

**Location 177:**

**City:** Vinnytsia

**Country:** Ukraine

**Facility:** Research Site

**Zip:** 21029

**Location 178:**

**City:** Ha Noi

**Country:** Vietnam

**Facility:** Research Site

**Zip:** 100000

**Location 179:**

**City:** Hanoi

**Country:** Vietnam

**Facility:** Research Site

**Zip:** 10000

**Location 180:**

**City:** Ho Chi Minh

**Country:** Vietnam

**Facility:** Research Site

**Zip:** 700000

#### Overall Officials

**Official 1:**

**Affiliation:** Royal Brompton Hospital, United Kingdom

**Name:** Andrew Menzies-Gow, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Menzies-Gow A, Ponnarambil S, Downie J, Bowen K, Hellqvist A, Colice G. DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 21;21(1):279. doi: 10.1186/s12931-020-01541-7.

**PMID:** 33087119

#### See Also Links

**Label:** Statistical Analysis Plan (SAP)

**URL:** https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5180C00018&amp;attachmentIdentifier=8a2b972e-4a6e-43c5-af7a-ae92fb0c49f3&amp;fileName=d5180c00018-sap-ed-3-redact.pdf&amp;versionIdentifier=

**Label:** Protocol

**URL:** https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5180C00018&amp;attachmentIdentifier=50cb4a27-8cdd-456e-8557-fdeccbd69d40&amp;fileName=d5180c00018-csp-v6-redact.pdf&amp;versionIdentifier=

**Label:** CSR Synopsis

**URL:** https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5180C00018&amp;attachmentIdentifier=d7be4478-ea53-4972-9b54-6771c586611a&amp;fileName=d5180c00018-study-synopsis-redact.pdf&amp;versionIdentifier=

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-04-12

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1878920

- Type Abbrev: Prot

- Upload Date: 2022-10-24T07:03

- Date: 2021-11-03

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 983432

- Type Abbrev: SAP

- Upload Date: 2022-10-24T07:03

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2022-11-17

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** The subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION are included in both Rand Pbo and Pbo to Teze arms. Their data collected during the placebo (predecessor) period are contained within the Rand Pbo arm, while data collected after the first dose of tezepelumab in DESTINATION are presented in the Pbo to Teze arm. Note the primary objective in the Outcome Measures section presents on-treatment safety as opposed to on-study safety.

#### Event Groups

**Group ID:** EG000

**Title:** NAVIGATOR Rand Teze

**Deaths Num Affected:** 8

**Deaths Num At Risk:** 528

**Description:** All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.

**ID:** EG000

**Other Num Affected:** 390

**Other Num at Risk:** 528

**Serious Number Affected:** 82

**Serious Number At Risk:** 528

**Title:** NAVIGATOR Rand Teze

**Group ID:** EG001

**Title:** NAVIGATOR Rand Pbo

**Deaths Num Affected:** 5

**Deaths Num At Risk:** 531

**Description:** All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching to tezepelumab in DESTINATION, data collected during the placebo (predecessor) period are contained in this column, while data collected after the first dose of tezepelumab in DESTINATION are presented in the NAVIGATOR Pbo to Teze arm.

**ID:** EG001

**Other Num Affected:** 384

**Other Num at Risk:** 531

**Serious Number Affected:** 94

**Serious Number At Risk:** 531

**Title:** NAVIGATOR Rand Pbo

**Group ID:** EG002

**Title:** NAVIGATOR Pbo to Teze

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 206

**Description:** All subjects randomised to placebo in the NAVIGATOR predecessor and re-randomised to tezepelumab in DESTINATION. Only data collected after the first dose of tezepelumab in DESTINATION are presented in this column.

**ID:** EG002

**Other Num Affected:** 98

**Other Num at Risk:** 206

**Serious Number Affected:** 17

**Serious Number At Risk:** 206

**Title:** NAVIGATOR Pbo to Teze

**Group ID:** EG003

**Title:** SOURCE Rand Teze

**Deaths Num Affected:** 2

**Deaths Num At Risk:** 74

**Description:** All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.

**ID:** EG003

**Other Num Affected:** 53

**Other Num at Risk:** 74

**Serious Number Affected:** 18

**Serious Number At Risk:** 74

**Title:** SOURCE Rand Teze

**Group ID:** EG004

**Title:** SOURCE Rand Pbo

**Deaths Num At Risk:** 76

**Description:** All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching to tezepelumab in DESTINATION, data collected during the placebo (predecessor) period are contained in this column, while data collected after the first dose of tezepelumab in DESTINATION are presented in the SOURCE Pbo to Teze arm.

**ID:** EG004

**Other Num Affected:** 58

**Other Num at Risk:** 76

**Serious Number Affected:** 19

**Serious Number At Risk:** 76

**Title:** SOURCE Rand Pbo

**Group ID:** EG005

**Title:** SOURCE Pbo to Teze

**Deaths Num At Risk:** 32

**Description:** All subjects randomised to placebo in the SOURCE predecessor and re-randomised to tezepelumab in DESTINATION. Only data collected after the first dose of tezepelumab in DESTINATION are presented in this column.

**ID:** EG005

**Other Num Affected:** 23

**Other Num at Risk:** 32

**Serious Number Affected:** 4

**Serious Number At Risk:** 32

**Title:** SOURCE Pbo to Teze

**Frequency Threshold:** 3

#### Other Events

**Term:** Sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Traumatic haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Rhinitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Sinusitis bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Upper respiratory tract infection bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Vaginal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Hyperlipidaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Type 2 diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Vertebral foraminal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Hyposmia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Spinal cord disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Gastrooesophageal reflux disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Acute sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Bronchitis bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Bronchitis viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Oral candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Pharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Pneumonia haemophilus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Suspected covid-19

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Tinea versicolour

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Viral rhinitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Viral upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Vulval abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Facial bones fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Joint dislocation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Ligament sprain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Glucose tolerance impaired

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Spinal osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Anosmia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Cerebral arteriosclerosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Cerebrovascular disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Asthma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Nasal polyps

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Rhinitis allergic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Sleep apnoea syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Acne

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Dry skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Photodermatosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Rash macular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Cataract

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Retinal tear

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Dental caries

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Impaired healing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Influenza like illness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Hypersensitivity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Covid-19

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Chronic sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Cystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Lower respiratory tract infection bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Otitis media

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

#### Serious Events

**Term:** Cardiac failure congestive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 528

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Viral upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Head injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Hip fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Coronary artery disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 528

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Ligament sprain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Lower limb fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Periprocedural myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Radius fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Road traffic accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Skin laceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Coronary artery occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Ulna fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Ligament rupture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 528

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Spinal compression fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Tendon rupture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Tibia fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Blood creatine phosphokinase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Diabetes mellitus inadequate control

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Diabetic ketoacidosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Muscle necrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Myocarditis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Gout

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Myositis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Type 1 diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Amyotrophy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Arthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Bone cyst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Exostosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Intervertebral disc protrusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Lumbar spinal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Invasive breast carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Polyarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Prinzmetal angina

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Squamous cell carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Spinal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Spondylolisthesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Supraventricular tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 2

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Ventricular extrasystoles

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Encephalocele

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Term:** Immune thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Hypertrophic cardiomyopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Vertigo positional

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cataract

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 531

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Anal fistula

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Uveitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Diverticular perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Acute left ventricular failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Gastric polyps

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Term:** Ileus paralytic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Inguinal hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 531

**Num Events:** 3

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Large intestine polyp

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Rectal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 528

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Oesophageal achalasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pancreatitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pancreatitis necrotising

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 531

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Impaired healing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Aortic valve stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cholecystitis chronic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Anaphylactic reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cholecystitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Drug-induced liver injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Drug hypersensitivity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Atrial flutter

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Breast abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Bacterial pyelonephritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Atrial tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Covid-19

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 528

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 531

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Covid-19 pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 528

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 531

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 3

**Num At Risk:** 74

**Num Events:** 3

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 531

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** H1n1 influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 531

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Gastroenteritis viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cardiac arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Intervertebral discitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Lower respiratory tract infection bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 531

**Num Events:** 5

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Meningitis bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pneumonia bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 528

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 531

**Num Events:** 2

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pneumonia haemophilus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Term:** Cardiac failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Osteomyelitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pneumonia streptococcal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Periorbital cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num Affected:** 2

**Num At Risk:** 76

**Num Events:** 2

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pneumonia klebsiella

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Ovarian germ cell teratoma benign

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Term:** Basal cell carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 531

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Benign neoplasm of thyroid gland

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Colon adenoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Colon cancer stage iv

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Endometrial cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Malignant melanoma in situ

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 528

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Neurilemmoma benign

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Prostate cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Prostatic adenoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Squamous cell carcinoma of the oral cavity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Thymoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Uterine leiomyoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Acute kidney injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Glomerulonephritis membranous

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cerebrovascular accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Renal colic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cubital tunnel syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Haemorrhagic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Asthma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 14

**Num At Risk:** 528

**Num Events:** 18

**Group ID:** EG001

**Num Affected:** 41

**Num At Risk:** 531

**Num Events:** 79

**Group ID:** EG002

**Num Affected:** 5

**Num At Risk:** 206

**Num Events:** 6

**Group ID:** EG003

**Num Affected:** 3

**Num At Risk:** 74

**Num Events:** 5

**Group ID:** EG004

**Num Affected:** 8

**Num At Risk:** 76

**Num Events:** 11

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Idiopathic generalised epilepsy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Intracranial aneurysm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Term:** Lumbar radiculopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Term:** Migraine

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Myelopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Ruptured cerebral aneurysm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Transient ischaemic attack

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Term:** Disruptive mood dysregulation disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Nephrolithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Obstruction gastric

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Chest discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Atypical pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cholecystitis infective

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Herpes zoster oticus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Diverticulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 528

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Gastroenteritis salmonella

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pneumonia viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 528

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Incisional hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Lumbar vertebral fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Type 2 diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Colorectal cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Seizure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Abortion spontaneous

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Pregnancy, puerperium and perinatal conditions

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 528

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Bipolar disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Acute kidney injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 74

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Ureterolithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Benign prostatic hyperplasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Ovarian cyst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Uterine prolapse

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Asthma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 16

**Num At Risk:** 528

**Num Events:** 20

**Group ID:** EG001

**Num Affected:** 43

**Num At Risk:** 531

**Num Events:** 91

**Group ID:** EG002

**Num Affected:** 5

**Num At Risk:** 206

**Num Events:** 6

**Group ID:** EG003

**Num Affected:** 5

**Num At Risk:** 74

**Num Events:** 7

**Group ID:** EG004

**Num Affected:** 8

**Num At Risk:** 76

**Num Events:** 12

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Bronchial secretion retention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Eosinophilic pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Haemothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Nasal polyps

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pulmonary sarcoidosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Hyperparathyroidism primary

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Dermatitis contact

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cyanosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Peripheral arterial occlusive disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Colitis ischaemic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Umbilical hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 76

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Gait disturbance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cholecystitis chronic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 206

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 528

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Anal abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Appendicitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Lower respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Lung abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 528

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 531

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pneumonia aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pneumonia staphylococcal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 531

**Group ID:** EG002

**Num At Risk:** 206

**Group ID:** EG003

**Num At Risk:** 74

**Group ID:** EG004

**Num At Risk:** 76

**Group ID:** EG005

**Num At Risk:** 32

**Time Frame:** Baseline (Week 0 in predecessor study) to long-term extension completion (either weeks 104 or 116). Includes AEs with onset date between the date of first dose of IP and and the long-term extension completion or withdrawal date (on-study period)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 528

**Group ID:** BG001

**Value:** 531

**Group ID:** BG002

**Value:** 74

**Group ID:** BG003

**Value:** 76

**Group ID:** BG004

**Value:** 1209

**Units:** Participants

### Group

**ID:** BG000

**Title:** NAVIGATOR Rand Teze

**Description:** All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.

### Group

**ID:** BG001

**Title:** NAVIGATOR Rand Pbo

**Description:** All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study and regardless of their treatment assignment in DESTINATION.

### Group

**ID:** BG002

**Title:** SOURCE Rand Teze

**Description:** All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.

### Group

**ID:** BG003

**Title:** SOURCE Rand Pbo

**Description:** All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study and regardless of their treatment assignment in DESTINATION.

### Group

**ID:** BG004

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 41

#### Measurement

**Group ID:** BG001

**Value:** 41

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 82

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 391

#### Measurement

**Group ID:** BG001

**Value:** 416

#### Measurement

**Group ID:** BG002

**Value:** 58

#### Measurement

**Group ID:** BG003

**Value:** 62

#### Measurement

**Group ID:** BG004

**Value:** 927

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 96

#### Measurement

**Group ID:** BG001

**Value:** 74

#### Measurement

**Group ID:** BG002

**Value:** 16

#### Measurement

**Group ID:** BG003

**Value:** 14

#### Measurement

**Group ID:** BG004

**Value:** 200

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 16.3

**Value:** 49.9

#### Measurement

**Group ID:** BG001

**Spread:** 15.9

**Value:** 49.0

#### Measurement

**Group ID:** BG002

**Spread:** 12.1

**Value:** 53.5

#### Measurement

**Group ID:** BG003

**Spread:** 11.9

**Value:** 53.4

#### Measurement

**Group ID:** BG004

**Spread:** 15.7

**Value:** 49.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 335

#### Measurement

**Group ID:** BG001

**Value:** 337

#### Measurement

**Group ID:** BG002

**Value:** 49

#### Measurement

**Group ID:** BG003

**Value:** 45

#### Measurement

**Group ID:** BG004

**Value:** 766

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 193

#### Measurement

**Group ID:** BG001

**Value:** 194

#### Measurement

**Group ID:** BG002

**Value:** 25

#### Measurement

**Group ID:** BG003

**Value:** 31

#### Measurement

**Group ID:** BG004

**Value:** 443

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 83

#### Measurement

**Group ID:** BG001

**Value:** 81

#### Measurement

**Group ID:** BG002

**Value:** 10

#### Measurement

**Group ID:** BG003

**Value:** 14

#### Measurement

**Group ID:** BG004

**Value:** 188

**Class Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 445

#### Measurement

**Group ID:** BG001

**Value:** 450

#### Measurement

**Group ID:** BG002

**Value:** 64

#### Measurement

**Group ID:** BG003

**Value:** 62

#### Measurement

**Group ID:** BG004

**Value:** 1021

**Class Title:** Not Hispanic or Latino

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 1

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

#### Measurement

**Group ID:** BG000

**Value:** 146

#### Measurement

**Group ID:** BG001

**Value:** 149

#### Measurement

**Group ID:** BG002

**Value:** 11

#### Measurement

**Group ID:** BG003

**Value:** 11

#### Measurement

**Group ID:** BG004

**Value:** 317

**Class Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 30

#### Measurement

**Group ID:** BG001

**Value:** 31

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 62

**Class Title:** Black of African American

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 1

**Class Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 19

#### Measurement

**Group ID:** BG001

**Value:** 23

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 43

**Class Title:** Other

#### Measurement

**Group ID:** BG000

**Value:** 332

#### Measurement

**Group ID:** BG001

**Value:** 327

#### Measurement

**Group ID:** BG002

**Value:** 62

#### Measurement

**Group ID:** BG003

**Value:** 64

#### Measurement

**Group ID:** BG004

**Value:** 785

**Class Title:** White

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Restrictive Agreement:** True
### Point of Contact
**Email:** information.center@astrazeneca.com
**Organization:** AstraZeneca
**Phone:** +1 302 885 1180
**Title:** Global Clinical Head
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.35
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.51
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Rate Ratio
**Parameter Value:** 0.42
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.38
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.96
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Rate Ratio
**Parameter Value:** 0.61
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.71
- **Spread:** 
- **Upper Limit:** 0.95
- **Value:** 0.82
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.70
- **Spread:** 
- **Upper Limit:** 2.20
- **Value:** 1.93
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.76
- **Spread:** 
- **Upper Limit:** 1.51
- **Value:** 1.07
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 1.27
- **Spread:** 
- **Upper Limit:** 2.45
- **Value:** 1.76
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49.62
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 62.66
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47.15
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.97
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.76
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.14
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.55
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.00
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.85
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12.45
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.14
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17.99
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.64
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.00
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.55
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.00
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 917.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 699.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 129.4
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100.0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
**Title:** Annualized Asthma Exacerbation Rate (AAER)
**Type:** SECONDARY
**Unit of Measure:** events per year
##### Group
**Description:** All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
**ID:** OG000
**Title:** NAVIGATOR Rand Teze
##### Group
**Description:** All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
**ID:** OG001
**Title:** NAVIGATOR Rand Pbo
##### Group
**Description:** All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
**ID:** OG002
**Title:** SOURCE Rand Teze
##### Group
**Description:** All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
**ID:** OG003
**Title:** SOURCE Rand Pbo
#### Outcome Measure 2
**Description:** Includes adverse events with an onset date between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set. Exposure adjusted rates are defined as number of subjects with AEs divided by total time at risk across all subjects, multiplied by 100
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
**Title:** Exposure Adjusted Incidence Rates of AEs/SAEs
**Type:** PRIMARY
**Unit of Measure:** Patients with AEs per 100 person-years
##### Group
**Description:** All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
**ID:** OG000
**Title:** NAVIGATOR Rand Teze
##### Group
**Description:** All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
**ID:** OG001
**Title:** NAVIGATOR Rand Pbo
##### Group
**Description:** All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
**ID:** OG002
**Title:** SOURCE Rand Teze
##### Group
**Description:** All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
**ID:** OG003
**Title:** SOURCE Rand Pbo
#### Outcome Measure 3
**Description:** Includes time between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
**Title:** Total Time at Risk
**Type:** PRIMARY
**Unit of Measure:** Year
##### Group
**Description:** All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
**ID:** OG000
**Title:** NAVIGATOR Rand Teze
##### Group
**Description:** All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
**ID:** OG001
**Title:** NAVIGATOR Rand Pbo
##### Group
**Description:** All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
**ID:** OG002
**Title:** SOURCE Rand Teze
##### Group
**Description:** All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
**ID:** OG003
**Title:** SOURCE Rand Pbo
### Participant Flow Module
#### Group
**Description:** All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
**ID:** FG000
**Title:** NAVIGATOR Rand Teze
#### Group
**Description:** All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching to tezepelumab in DESTINATION, data collected during the placebo (predecessor) period are contained in this column, while data collected after the first dose of tezepelumab in DESTINATION are presented in the NAVIGATOR Pbo to Teze arm.
**ID:** FG001
**Title:** NAVIGATOR Rand Pbo
#### Group
**Description:** All subjects randomised to placebo in the NAVIGATOR predecessor and re-randomised to tezepelumab in DESTINATION. Only data collected after the first dose of tezepelumab in DESTINATION are presented in this column.
**ID:** FG002
**Title:** NAVIGATOR Pbo to Teze
#### Group
**Description:** All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
**ID:** FG003
**Title:** SOURCE Rand Teze
#### Group
**Description:** All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching to tezepelumab in DESTINATION, data collected during the placebo (predecessor) period are contained in this column, while data collected after the first dose of tezepelumab in DESTINATION are presented in the SOURCE Pbo to Teze arm.
**ID:** FG004
**Title:** SOURCE Rand Pbo
#### Group
**Description:** All subjects randomised to placebo in the SOURCE predecessor and re-randomised to tezepelumab in DESTINATION. Only data collected after the first dose of tezepelumab in DESTINATION are presented in this column.
**ID:** FG005
**Title:** SOURCE Pbo to Teze
#### Period
**Title:** Predecessor Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 15
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 5
###### Reason
**Group ID:** FG004
**Number of Subjects:** 2
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Did not receive treatment / Non-compliance with protocol / did not complete safety follow-up visits
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 529
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 532
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 74
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 76
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** Received Treatment
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 528
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 531
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 74
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 76
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 513
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 509
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 68
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 73
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 16
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 23
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
#### Period
**Title:** Long Term Extension (DESTINATION)
##### Withdraw
**Type:** Due to COVID-19 pandemic
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 1
##### Withdraw
**Type:** Did not complete safety follow-up visits
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Pregnancy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 3
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 415
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 206
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 206
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 60
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 32
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 32
##### Milestone
**Type:** Received Treatment
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 415
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 206
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 205
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 60
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 32
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 32
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 400
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 200
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 198
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 58
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 28
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 31
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 15
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 1
**Pre-Assignment Details:** Of the 1209 patients randomized and dosed in predecessor studies, 951 were randomised in DESTINATION and 950 received treatment. The patients receiving tezepelumab in the predecessors continued to receive tezepelumab, while patients receiving placebo in the predecessors were re-randomized 1:1 to either receive tezepelumab in DESTINATION or to continue placebo, resulting in a 3:1 randomization ratio in DESTINATION.
**Recruitment Details:** Participants who completed treatment and attended end of treatment visit in predecessor studies NAVIGATOR (NCT03347279) or SOURCE (NCT03406078) were eligible for this long-term extension study. In the predecessor studies, a total of 1059 and 150 subjects were randomised and dosed in NAVIGATOR and SOURCE respectively. In DESTINATION, a total of 951 subjects (827 from NAVIGATOR and 124 from SOURCE) were randomised at 182 centres in 18 countries to receive treatment with tezepelumab or placebo.
**Has Results:** True