## Protocol Section
### Identification Module
**NCT ID:** NCT00660179

**Acronym:** SERAPHIN

**Brief Title:** Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

**Official Title:** A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

#### Organization Study ID Info
**ID:** AC-055-302
#### Organization
**Class:** INDUSTRY
**Full Name:** Actelion
### Status Module
#### Completion Date
**Date:** 2012-04

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2012-10-29

**Type:** ESTIMATED

**Disp First Submit Date:** 2012-10-23
**Disp First Submit QC Date:** 2012-10-23

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-09-28

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-09-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-05-05

**Type:** ESTIMATED

**Results First Submit Date:** 2013-11-05

**Results First Submit QC Date:** 2014-04-03

#### Start Date
**Date:** 2008-05

**Status Verified Date:** 2015-08

#### Study First Post Date
**Date:** 2008-04-17
**Type:** ESTIMATED
**Study First Submit Date:** 2008-04-14
**Study First Submit QC Date:** 2008-04-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Actelion

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.

### Conditions Module

**Conditions:**

- Pulmonary Arterial Hypertension

**Keywords:**

- pulmonary arterial hypertension SERAPHIN

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 742

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Macitentan (ACT-064992) tablet, 3 mg, once daily

**Intervention Names:**

- Drug: macitentan (ACT-064992)

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Macitentan (ACT-064992) tablet, 10 mg, once daily

**Intervention Names:**

- Drug: macitentan (ACT-064992)

**Label:** 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Matching placebo, once daily

**Intervention Names:**

- Drug: placebo

**Label:** 3

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** Tablet, 3 mg dosage, once daily

**Name:** macitentan (ACT-064992)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** Tablet, 10 mg dosage, once daily

**Name:** macitentan (ACT-064992)

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- 3

**Description:** Matching placebo, once daily

**Name:** placebo

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).

Other worsening of PAH was defined by the combined occurrence of all the following 3 events:

At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.

AND worsening of PAH symptoms including at least one of the following:

a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy

AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics

**Measure:** Summary of the First Causes of Morbidity or Mortality

**Time Frame:** Up to end of treatment (Up to 36 months)

#### Primary Outcomes

**Description:** Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).

Other worsening of PAH was defined by the combined occurrence of all the following 3 events:

At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.

AND worsening of PAH symptoms including at least one of the following:

a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy

AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics

**Measure:** Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)

**Time Frame:** Up to end of treatment (data presented up to month 36)

#### Secondary Outcomes

**Description:** Events of PAH or hospitalization for PAH up to the end of treatment included: death due to PAH, or onset of a treatment-emergent adverse event with a fatal outcome due to PAH occurring up to 4 weeks after the end of treatment, or hospitalisation for PAH up to the end of treatment.

**Measure:** Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)

**Time Frame:** Up to end of treatment (data presented up to month 36)

**Description:** Events of death due to any cause up to the end of treatment (plus 7 days)

**Measure:** Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)

**Time Frame:** Up to end of treatment (data presented up to month 36)

**Description:** Events of death due to any cause up to the end of study (EOS). The initiation of EOS procedure occurred when the target of 285 events was expected to have been achieved (30 January 2012).

**Measure:** Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)

**Time Frame:** Up to end of study (data presented up to month 36)

**Description:** The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.

**Measure:** Change From Baseline to Month 6 in 6-minute Walk Distance

**Time Frame:** Baseline to month 6

**Description:** Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope.

Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope.

Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope.

Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA.

**Measure:** Number of Patients With Improvements in World Health Organization Functional Class From Baseline to Month 6

**Time Frame:** Baseline to month 6

**Description:** In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.

**Measure:** Pulmonary Vascular Resistance at Baseline and Month 6

**Time Frame:** Baseline to month 6

**Description:** In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.

**Measure:** Cardiac Index at Baseline and Month 6

**Time Frame:** Baseline to month 6

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Signed informed consent prior to initiation of any study mandated procedure.
2. Patients with symptomatic pulmonary arterial hypertension (PAH) in modified World Health Organization (WHO) functional class II to IV.
3. Patients with the following types of pulmonary arterial hypertension (PAH) belonging to groups 1.1 to 1.3 of the Venice classification:

   * Idiopathic (IPAH);
   * Familial (FPAH); or
   * Related to:

     * Collagen vascular disease;
     * Simple, congenital systemic-to-pulmonary shunts at least 1 year post surgical repair;
     * Human immunodeficiency virus (HIV) infection; or
     * Drugs and toxins.
4. PAH diagnosis confirmed by hemodynamic evaluation performed prior to randomization and showing all of the following:

   * Mean pulmonary artery pressure (mPAP) \> 25 mmHg at rest;
   * Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) \< 15 mmHg; and
   * Pulmonary vascular resistance (PVR) at rest \>= 320 dyn×sec/cm\^5.
5. 6-minute walk distance (6MWD) \>= 50 m.
6. Men or women \> 12 years of age (women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception).

Exclusion Criteria:

1. PAH associated with portal hypertension, thyroid disorders, glycogen storage disease, Gaucher''s disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy.
2. PAH associated with non corrected simple congenital systemic-to-pulmonary shunts, and combined and complex systemic-to-pulmonary shunts, corrected or non corrected.
3. PAH associated with significant venous or capillary involvement (PCWP \> 15 mmHg), known pulmonary veno-occlusive disease, and pulmonary capillary hemangiomatosis.
4. Persistent pulmonary hypertension of the newborn.
5. Pulmonary Hypertension belonging to groups 2 to 5 of the Venice classification.
6. Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 70% and FEV1 \< 65% of predicted value after bronchodilator administration.
7. Moderate to severe restrictive lung disease: total lung capacity (TLC) \< 60% of predicted value.
8. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
9. Estimated creatinine clearance \< 30 mL/min
10. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal.
11. Hemoglobin \< 75% of the lower limit of the normal range.
12. Systolic blood pressure \< 100 mmHg.
13. Acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements.
14. Pregnant or breast-feeding.
15. Known concomitant life-threatening disease with a life expectancy \< 12 months.
16. Body weight \< 40 kg.
17. Any condition that prevents compliance with the protocol or adherence to therapy.
18. Recently started (\< 8 weeks prior to randomization) or planned cardio-pulmonary rehabilitation program based on exercise.
19. Treatment with endothelin receptor antagonists (ERAs) within 3 months prior to randomization.
20. Systemic treatment within 4 week prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mammalian target of rapamycin (mTOR) inhibitors).
21. Treatment with cytochrome P3A (CYP3A) inducers within 4 weeks prior to randomization
22. Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
23. Planned treatment, or treatment, with another investigational drug within 1 month prior to randomization.

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** University of Alabama at Birmingham

**State:** Alabama

**Zip:** 35249-0001

**Location 2:**

**City:** Pheonix

**Country:** United States

**Facility:** Arizona Pulmonary Specialists

**State:** Arizona

**Zip:** 85013

**Location 3:**

**City:** Los Angeles

**Country:** United States

**Facility:** GLVA Healthcare Center

**State:** California

**Location 4:**

**City:** San Diego

**Country:** United States

**Facility:** University of California, San Diego

**State:** California

**Location 5:**

**City:** Santa Barbara

**Country:** United States

**Facility:** Santa Barbara Cottage Hospital

**State:** California

**Location 6:**

**City:** Torrance

**Country:** United States

**Facility:** Liu Center for Pulmonary Hypertension

**State:** California

**Location 7:**

**City:** Denver

**Country:** United States

**Facility:** University of Colorado Health Sciences Center

**State:** Colorado

**Location 8:**

**City:** Jacksonville

**Country:** United States

**Facility:** Mayo Clinic, Jacksonville

**State:** Florida

**Location 9:**

**City:** Atlanta

**Country:** United States

**Facility:** Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease

**State:** Georgia

**Zip:** 30322

**Location 10:**

**City:** Atlanta

**Country:** United States

**Facility:** Pulmonary & Critical Care of Atlanta

**State:** Georgia

**Zip:** 30342

**Location 11:**

**City:** Decatur

**Country:** United States

**Facility:** Southeastern Lung Care

**State:** Georgia

**Location 12:**

**City:** Chicago

**Country:** United States

**Facility:** University of Chicago Hospitals

**State:** Illinois

**Location 13:**

**City:** Iowa City

**Country:** United States

**Facility:** University of Iowa

**State:** Iowa

**Location 14:**

**City:** Kansas City

**Country:** United States

**Facility:** University of Kansas Medical Center

**State:** Kansas

**Zip:** 66160

**Location 15:**

**City:** Louisville

**Country:** United States

**Facility:** Kentuckiana Pulmonary Associate, PLLC

**State:** Kentucky

**Location 16:**

**City:** New Orleans

**Country:** United States

**Facility:** Medical Center of Louisiana at New Orleans

**State:** Louisiana

**Location 17:**

**City:** Portland

**Country:** United States

**Facility:** Maine Medical Center

**State:** Maine

**Zip:** 04102

**Location 18:**

**City:** Baltimore

**Country:** United States

**Facility:** University of Maryland School of Medicine

**State:** Maryland

**Zip:** 21201

**Location 19:**

**City:** Boston

**Country:** United States

**Facility:** Boston University School of Medicine

**State:** Massachusetts

**Location 20:**

**City:** Boston

**Country:** United States

**Facility:** Pulmonary/Critical Care Division/Tufts New England Medical Center

**State:** Massachusetts

**Location 21:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan

**State:** Michigan

**Location 22:**

**City:** St. Louis

**Country:** United States

**Facility:** Washington University School of Medicine

**State:** Missouri

**Zip:** 63110

**Location 23:**

**City:** New Brunswick

**Country:** United States

**Facility:** University of NJ - Robert Wood Johnson Medical School

**State:** New Jersey

**Location 24:**

**City:** New York

**Country:** United States

**Facility:** Columbia University Medical Center - Pediatric Cardiology

**State:** New York

**Location 25:**

**City:** Durham

**Country:** United States

**Facility:** Duke University Medical Center

**State:** North Carolina

**Location 26:**

**City:** Cincinnati

**Country:** United States

**Facility:** University of Cincinnati Ohio Heart Health Center

**State:** Ohio

**Location 27:**

**City:** Columbus

**Country:** United States

**Facility:** Ohio State University

**State:** Ohio

**Zip:** 43210

**Location 28:**

**City:** Nashville

**Country:** United States

**Facility:** Vanderbilt University Medical Center

**State:** Tennessee

**Location 29:**

**City:** Dallas

**Country:** United States

**Facility:** University of Texas Medical Center - St. Paul University

**State:** Texas

**Zip:** 75235

**Location 30:**

**City:** Houston

**Country:** United States

**Facility:** Baylor College of Medicine and the Methodist Hospital

**State:** Texas

**Zip:** 77030

**Location 31:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Dept. of Pulmonary Medicine - Latter Day Saints Hospital

**State:** Utah

**Location 32:**

**City:** Norfolk

**Country:** United States

**Facility:** Sentara Hospital T/A Sentara Cardiovascular Research Institute

**State:** Virginia

**Zip:** 23507

**Location 33:**

**City:** Milwaukee

**Country:** United States

**Facility:** Comprehensive Cardiovascular Care Group

**State:** Wisconsin

**Location 34:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** Fundacion Favaloro

**Zip:** C1093AAS

**Location 35:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** Hospital Britanico

**Location 36:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** Sanatorio MITRE

**Location 37:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** SANATORIO OTAMENDI y MIROLI

**Location 38:**

**City:** Cordoba

**Country:** Argentina

**Facility:** Htal Italiano Cordoba

**Location 39:**

**City:** Cordoba

**Country:** Argentina

**Facility:** Htla privado de Cordoba

**Location 40:**

**City:** Corrientes

**Country:** Argentina

**Facility:** Instituto Cardiologia Corrientes

**Location 41:**

**City:** Santa Fe

**Country:** Argentina

**Facility:** 'Hospital Italiano - Garibaldi de Rosario

**Location 42:**

**City:** Darlinghurst, NSW

**Country:** Australia

**Facility:** St. Vincent's Hospital

**Zip:** 2010

**Location 43:**

**City:** Melbourne, VIC

**Country:** Australia

**Facility:** The Alfred Hospital

**Zip:** 3181

**Location 44:**

**City:** Sunshine Coast

**Country:** Australia

**Facility:** Royal Brisbane Hospital

**Zip:** 4558

**Location 45:**

**City:** Vienna

**Country:** Austria

**Facility:** Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology

**Location 46:**

**City:** Minsk

**Country:** Belarus

**Facility:** Republican reserach - Pratical Centre of Cardilogy

**Zip:** 220036

**Location 47:**

**City:** Minsk

**Country:** Belarus

**Facility:** Minsk Regional Clinical Hospital

**Zip:** 223040

**Location 48:**

**City:** Vitebsk

**Country:** Belarus

**Facility:** Vitebsk Regional Clinical Hospital

**Zip:** 210037

**Location 49:**

**City:** Leuven

**Country:** Belgium

**Facility:** University Hospital Gasthuisberg / Kliniekhoofd, Interne Geneeskunde - I.G. Pneumologie

**Location 50:**

**City:** Sofia

**Country:** Bulgaria

**Facility:** Specialized Hospital for Active Treatment of Cardio-Vascular Diseases / Department of Pediatric Cardiology

**Zip:** 1309

**Location 51:**

**City:** London

**Country:** Canada

**Facility:** London Health Sciences Centre / Victoria Hospital

**State:** Ontario

**Location 52:**

**City:** Saint-Foy

**Country:** Canada

**Facility:** L'Hopital Laval

**State:** Quebec

**Location 53:**

**City:** Calgary

**Country:** Canada

**Facility:** Peter Lougheed Centre

**Location 54:**

**City:** Toronto

**Country:** Canada

**Facility:** Toronto General Hospital

**Location 55:**

**City:** Vancouver

**Country:** Canada

**Facility:** Vancouver General Hospital

**Zip:** V6Z 1Y6

**Location 56:**

**City:** Santiago de Chile

**Country:** Chile

**Facility:** 'Pontificia Universidad Catolica de Chile

**Location 57:**

**City:** Santiago de Chile

**Country:** Chile

**Facility:** Hospital del Torax

**Location 58:**

**City:** Santiago

**Country:** Chile

**Facility:** Hospital San Juan de Dios

**Location 59:**

**City:** Guangzhou

**Country:** China

**Facility:** Guangdong General Hospital, Cardiology Department

**State:** Guangdong

**Zip:** 510080

**Location 60:**

**City:** Nanjing

**Country:** China

**Facility:** Jiangsu Province Hospital - Pneumology Department

**State:** Jiangsu

**Zip:** 210029

**Location 61:**

**City:** Beijing

**Country:** China

**Facility:** Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department

**Zip:** 100029

**Location 62:**

**City:** Beijing

**Country:** China

**Facility:** Peking Union Medcical College Hospital, Rheumatology Department

**Zip:** 100032

**Location 63:**

**City:** Beijing

**Country:** China

**Facility:** Chinese PLA General Hospital (301 Hospital), Cardiology Department

**Zip:** 100853

**Location 64:**

**City:** Shanghai

**Country:** China

**Facility:** Renji Hospital, Rheumatology Dept

**Zip:** 200001

**Location 65:**

**City:** Shanghai

**Country:** China

**Facility:** Zhongshan Hospital Fudan University, Cardiology Dept

**Zip:** 200032

**Location 66:**

**City:** Shanghai

**Country:** China

**Facility:** Renji Hospital, Cardiology Dept

**Zip:** 200127

**Location 67:**

**City:** Shanghai

**Country:** China

**Facility:** Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation

**Zip:** 200433

**Location 68:**

**City:** Bogota

**Country:** Colombia

**Facility:** Fundación Clínica Shaio

**Location 69:**

**City:** Floridablanca, Santander

**Country:** Colombia

**Facility:** 'Fundacion Cardiovascular de Colombia

**Location 70:**

**City:** Rijeka

**Country:** Croatia

**Facility:** Clinical Hospital Center

**Zip:** 51 000

**Location 71:**

**City:** Clamart

**Country:** France

**Facility:** Hôpital Antoine Béclère / Service de Pneumologie

**Zip:** 92140

**Location 72:**

**City:** Montpellier Cedex 5

**Country:** France

**Facility:** Hôpital Arnaud de Villeneuve Service des Maladies Respiratoires

**Zip:** 34295

**Location 73:**

**City:** Pessac

**Country:** France

**Facility:** Hopital Haut-Leveque - Maison du Haut-Leveque

**Zip:** 33604

**Location 74:**

**City:** Berlin

**Country:** Germany

**Facility:** Unfallkrankenhaus Berlin, Klinik für Innere Medizin

**Location 75:**

**City:** Dresden

**Country:** Germany

**Facility:** Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus

**Zip:** D-01307

**Location 76:**

**City:** Giessen

**Country:** Germany

**Facility:** Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med.

**Zip:** D-35392

**Location 77:**

**City:** Greifswald

**Country:** Germany

**Facility:** Universität Greifswald / Klinik für Innere Medizin B,

**Zip:** D-17487

**Location 78:**

**City:** Hamburg

**Country:** Germany

**Facility:** Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie

**Zip:** D-20246

**Location 79:**

**City:** Heidelberg

**Country:** Germany

**Facility:** Thoraxklinik am Universitätsklinikum Heidelberg

**Zip:** D-69126

**Location 80:**

**City:** Homburg/Saar

**Country:** Germany

**Facility:** Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V

**Zip:** D-66421

**Location 81:**

**City:** Koln

**Country:** Germany

**Facility:** Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie

**Zip:** D-50924

**Location 82:**

**City:** Leipzig

**Country:** Germany

**Facility:** Universtätsklinik Leipzig

**Zip:** 04103

**Location 83:**

**City:** Mainz

**Country:** Germany

**Facility:** Klinikum der Johannes Gutenberg-Universität / II. Medizinische Klinik und Poliklinik

**Zip:** D-55131

**Location 84:**

**City:** Munich

**Country:** Germany

**Facility:** Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie

**Zip:** D-81377

**Location 85:**

**City:** Regensburg

**Country:** Germany

**Facility:** Universitätsklinikum Regensburg / Innere Medizin II

**Zip:** 93053

**Location 86:**

**City:** Hong Kong

**Country:** Hong Kong

**Facility:** Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics

**Location 87:**

**City:** Hong Kong

**Country:** Hong Kong

**Facility:** Queen Mary Hospital / Division of Cardiology, Department of Medicine

**Location 88:**

**City:** Budapest

**Country:** Hungary

**Facility:** Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)

**Zip:** H-1096

**Location 89:**

**City:** Budapest

**Country:** Hungary

**Facility:** Semmelweis University, Pulmonolgy Clinic

**Zip:** H-1125

**Location 90:**

**City:** Szeged

**Country:** Hungary

**Facility:** University of Szeged Albert Szent-Györgyi Medical and Pharmaceutical Center, Faculty of General Medicine, II. Internal Medicine Clinic, Cardiology Center

**Location 91:**

**City:** Ahmedabad

**Country:** India

**Facility:** Life Care Institute of Medical Science & Research, Ahmedabad

**Zip:** 382428

**Location 92:**

**City:** Delhi

**Country:** India

**Facility:** G B Pant Hospital & Maulana Azad Medical College

**Zip:** 110049

**Location 93:**

**City:** Hyderabad

**Country:** India

**Facility:** Care Hospital

**Zip:** 500001

**Location 94:**

**City:** Mumbai

**Country:** India

**Facility:** King Edward VII Memorial Hospital (KEM) Hospital

**Zip:** 400 012

**Location 95:**

**City:** Mumbai

**Country:** India

**Facility:** P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine

**Zip:** 400016

**Location 96:**

**City:** Pune

**Country:** India

**Facility:** Deenanath Mangeshkar Hospital and Research Centre

**Zip:** 411 004

**Location 97:**

**City:** Haifa

**Country:** Israel

**Facility:** Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division

**Zip:** 34362

**Location 98:**

**City:** Petach - Tikvah

**Country:** Israel

**Facility:** Rabin Medical Center - Belinson campus - Pulmonary Institute

**Zip:** 49100

**Location 99:**

**City:** Rehovot

**Country:** Israel

**Facility:** Pulmonary Institute, Kaplan Medical Center

**Zip:** 76100

**Location 100:**

**City:** Tel Hashomer

**Country:** Israel

**Facility:** The pulmonary institute Sheba Medical centre

**Zip:** 52621

**Location 101:**

**City:** Tel-Aviv

**Country:** Israel

**Facility:** Sourasky Medical Center - Division of Pulmonary Medicine and Allergy

**Zip:** 64239

**Location 102:**

**City:** Roma

**Country:** Italy

**Facility:** Policlinico Umberto I, Cardiologia

**Zip:** 00161

**Location 103:**

**City:** Kuala Lumpur

**Country:** Malaysia

**Facility:** Institut Jantung Negara (National Heart Institute)

**Zip:** 50400

**Location 104:**

**City:** Mexico City

**Country:** Mexico

**Facility:** 'Instituto Nacional de Cardiología (INC) Ignacio Chávez

**Zip:** 14080

**Location 105:**

**City:** Monterrey Nuevo León

**Country:** Mexico

**Facility:** Unidad de Investigación Clinica en Medicina, SC

**Zip:** 64020

**Location 106:**

**City:** Nieuwegein

**Country:** Netherlands

**Facility:** St. Antonius ziekenhuis

**Zip:** 3435 CM

**Location 107:**

**City:** Oslo

**Country:** Norway

**Facility:** Aker University Dept of Cardilogy

**Zip:** N0514

**Location 108:**

**City:** Lima

**Country:** Peru

**Facility:** Hospital Alberto Sabogal Sologuren - EsSALUD

**Location 109:**

**City:** Lima

**Country:** Peru

**Facility:** IInstituto de Enfermedades Respiratorias, Clinica San Gabriel

**Location 110:**

**City:** Krakow

**Country:** Poland

**Facility:** Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ

**Zip:** 31-202

**Location 111:**

**City:** Warszawa

**Country:** Poland

**Facility:** Klinika Chorób Wewnętrznych Klatki Piersiowej

**Zip:** 01-138

**Location 112:**

**City:** Zabrze

**Country:** Poland

**Facility:** III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego

**Zip:** 41-800

**Location 113:**

**City:** Bucharest

**Country:** Romania

**Facility:** Institutul de boli cardiovasculare / Clinica de Cardiologie

**Zip:** 022328

**Location 114:**

**City:** Bucharest

**Country:** Romania

**Facility:** Institutul de Pneumologie "Marius Nasta" / I. Clinica de Pneumoftiziologie

**Zip:** 50159

**Location 115:**

**City:** Ekaterinburg

**Country:** Russian Federation

**Facility:** Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)

**Zip:** 620102

**Location 116:**

**City:** Kemerovo

**Country:** Russian Federation

**Facility:** Municipal Health Care Institution "Kemerovo Cardiology Dispensary"

**Zip:** 650002

**Location 117:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"

**Zip:** 105077

**Location 118:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** State Health Care Institution of Moscow "City Clinical Hospital #1 named after N. I. Pirogov"

**Zip:** 117049

**Location 119:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"

**Zip:** 121552

**Location 120:**

**City:** St. Petersburg

**Country:** Russian Federation

**Facility:** Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Rosmedtechnology

**Zip:** 194156

**Location 121:**

**City:** St. Petersburg

**Country:** Russian Federation

**Facility:** State Educational Institution of High Professional Education

**Zip:** 197 022

**Location 122:**

**City:** Tomsk

**Country:** Russian Federation

**Facility:** State Institution "Scientific Research Institute of Cardiology" of Tomsk Scientific Center of RAMS, Siberian branch

**Zip:** 634063

**Location 123:**

**City:** Tomsk

**Country:** Russian Federation

**Facility:** Tomsk Regional Clinical Hospital / Pulmonology Unit

**Zip:** 634063

**Location 124:**

**City:** Yaroslavl

**Country:** Russian Federation

**Facility:** Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"

**Zip:** 150 003

**Location 125:**

**City:** Belgrade

**Country:** Serbia

**Facility:** University Children's Hospital (UNIVERZITETSKA DEČJA KLINIKA)

**Zip:** 11000

**Location 126:**

**City:** Belgrade

**Country:** Serbia

**Facility:** University Clinical Center of Serbia / Institute for Lung Diseases and Tuberculosis

**Zip:** 11000

**Location 127:**

**City:** Belgrade

**Country:** Serbia

**Facility:** Zemun Clinical Hospital (Kliničko-bolnički centar "Zemun" ) / Department of Cardiology

**Zip:** 11080

**Location 128:**

**City:** Singapore

**Country:** Singapore

**Facility:** National University Hospital/ The Heart Institute

**Zip:** 168752

**Location 129:**

**City:** Singapore

**Country:** Singapore

**Facility:** Singapore General Hospital

**Zip:** 168752

**Location 130:**

**City:** Bratislava

**Country:** Slovakia

**Facility:** National Institute of Cardiovascular Diseases (Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH) / Department of Heart Transplantation

**Zip:** 833 48

**Location 131:**

**City:** Bratislava

**Country:** Slovakia

**Facility:** Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií), Department of Cardiology and Angiology

**Zip:** 833 48

**Location 132:**

**City:** Johannesburg

**Country:** South Africa

**Facility:** Netcare Milpark Hospital,Center for Chest Disease

**Zip:** 2000

**Location 133:**

**City:** Johannesburg

**Country:** South Africa

**Facility:** Chris Hani Baragwanath Hospital, Department of Cardiology

**Zip:** 27-11-033 8197

**Location 134:**

**City:** Parow

**Country:** South Africa

**Facility:** Tread Research

**Zip:** 7505

**Location 135:**

**City:** Somerset West

**Country:** South Africa

**Facility:** Block 4, Vergelegen Medi-Clinic

**Zip:** 7130

**Location 136:**

**City:** A Coruna

**Country:** Spain

**Facility:** Hospital Juan Canalejo Servicio de Neumología

**Zip:** 15006

**Location 137:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Universitario Vall d'Hebron, Pneumology Unit, Planta Baja Hospital General

**Zip:** 08035

**Location 138:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Clínico I Provincial, Servicio de Neumología.

**Zip:** 08036

**Location 139:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital 12 Octubre/ Cardiology department Planta 5a.

**Zip:** 20841

**Location 140:**

**City:** Malaga

**Country:** Spain

**Facility:** Hospital Clínico Virgen de la Victoria / Pneumology Unit,

**Zip:** 29010

**Location 141:**

**City:** Pontevedra

**Country:** Spain

**Facility:** Hospital Montecelo, Servicio de Neumología

**Zip:** 36771

**Location 142:**

**City:** Lund

**Country:** Sweden

**Facility:** University Hospital in Lund, Heart and Lung Division

**Zip:** SE-221 85

**Location 143:**

**City:** Uppsala

**Country:** Sweden

**Facility:** Servicio de Medicina Interna, Unidad de Hipertensión Pulmonar

**Zip:** 751 85

**Location 144:**

**City:** Taichung

**Country:** Taiwan

**Facility:** Taichung Veterans General Hospital / Division of Allergy, Immunology and Rheumatology

**Zip:** 40705

**Location 145:**

**City:** Taipei

**Country:** Taiwan

**Facility:** National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department

**Location 146:**

**City:** Bangkok

**Country:** Thailand

**Facility:** Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,

**Zip:** 10400

**Location 147:**

**City:** Bangkok

**Country:** Thailand

**Facility:** Siriraj Hospital/ Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University

**Zip:** 10700

**Location 148:**

**City:** Chiang Mai

**Country:** Thailand

**Facility:** Chiang Mai Hospital / Division of Rheumatology, Department of Medicine, Faculty of Medicine, Chiang Mai University

**Location 149:**

**City:** Khon Kaen

**Country:** Thailand

**Facility:** Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University

**Zip:** 40002

**Location 150:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Istanbul University Cardiology Institure

**Location 151:**

**City:** Dnepropetrovsk

**Country:** Ukraine

**Facility:** Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid

**Zip:** 49060

**Location 152:**

**City:** Lviv

**Country:** Ukraine

**Facility:** Danylo Halytskyi Lviv State Medical University

**Zip:** 79010

**Location 153:**

**City:** London

**Country:** United Kingdom

**Facility:** Royal Free Hospital

**Zip:** NW3 2QG

#### Overall Officials

**Official 1:**

**Affiliation:** Actelion

**Name:** Loic Perchenet, PhD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Pulido T, Adzerikho I, Channick RN, Delcroix M, Galie N, Ghofrani HA, Jansa P, Jing ZC, Le Brun FO, Mehta S, Mittelholzer CM, Perchenet L, Sastry BK, Sitbon O, Souza R, Torbicki A, Zeng X, Rubin LJ, Simonneau G; SERAPHIN Investigators. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013 Aug 29;369(9):809-18. doi: 10.1056/NEJMoa1213917.

**PMID:** 23984728

**Citation:** Di Scala L, Bacchi M, Bayer B, Turricchia S. Adjusting Overall Survival Estimates of Macitentan in Pulmonary Arterial Hypertension After Treatment Switching: Results from the SERAPHIN Study. Adv Ther. 2022 Sep;39(9):4346-4358. doi: 10.1007/s12325-022-02253-8. Epub 2022 Aug 1.

**PMID:** 35917059

**Citation:** Souza R, Delcroix M, Galie N, Jansa P, Mehta S, Pulido T, Rubin L, Sastry BKS, Simonneau G, Sitbon O, Torbicki A, Boyanova N, Chamitava L, Stein C, Channick RN. Long-Term Safety, Tolerability and Survival in Patients with Pulmonary Arterial Hypertension Treated with Macitentan: Results from the SERAPHIN Open-Label Extension. Adv Ther. 2022 Sep;39(9):4374-4390. doi: 10.1007/s12325-022-02199-x. Epub 2022 Jul 12.

**PMID:** 35819570

**Citation:** Torbicki A, Bacchi M, Delcroix M, Farber HW, Ghofrani HA, Hennessy B, Jansa P, Mehta S, Perchenet L, Pulido T, Rosenberg D, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Wei LJ, Channick R, Benza R. Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005095. doi: 10.1161/CIRCOUTCOMES.118.005095.

**PMID:** 31109190

**Citation:** Krause A, Zisowsky J, Dingemanse J. Modeling of pharmacokinetics, efficacy, and hemodynamic effects of macitentan in patients with pulmonary arterial hypertension. Pulm Pharmacol Ther. 2018 Apr;49:140-146. doi: 10.1016/j.pupt.2018.02.005. Epub 2018 Feb 28.

**PMID:** 29501590

**Citation:** McLaughlin VV, Hoeper MM, Channick RN, Chin KM, Delcroix M, Gaine S, Ghofrani HA, Jansa P, Lang IM, Mehta S, Pulido T, Sastry BKS, Simonneau G, Sitbon O, Souza R, Torbicki A, Tapson VF, Perchenet L, Preiss R, Verweij P, Rubin LJ, Galie N. Pulmonary Arterial Hypertension-Related Morbidity Is Prognostic for Mortality. J Am Coll Cardiol. 2018 Feb 20;71(7):752-763. doi: 10.1016/j.jacc.2017.12.010.

**PMID:** 29447737

**Citation:** Jansa P, Pulido T. Macitentan in Pulmonary Arterial Hypertension: A Focus on Combination Therapy in the SERAPHIN Trial. Am J Cardiovasc Drugs. 2018 Feb;18(1):1-11. doi: 10.1007/s40256-017-0260-1.

**PMID:** 29280064

**Citation:** Mehta S, Sastry BKS, Souza R, Torbicki A, Ghofrani HA, Channick RN, Delcroix M, Pulido T, Simonneau G, Wlodarczyk J, Rubin LJ, Jansa P, Hunsche E, Galie N, Perchenet L, Sitbon O. Macitentan Improves Health-Related Quality of Life for Patients With Pulmonary Arterial Hypertension: Results From the Randomized Controlled SERAPHIN Trial. Chest. 2017 Jan;151(1):106-118. doi: 10.1016/j.chest.2016.08.1473. Epub 2016 Sep 23. Erratum In: Chest. 2018 May;153(5):1287.

**PMID:** 27671974

**Citation:** Simonneau G, Channick RN, Delcroix M, Galie N, Ghofrani HA, Jansa P, Le Brun FO, Mehta S, Perchenet L, Pulido T, Sastry BK, Sitbon O, Souza R, Torbicki A, Rubin LJ. Incident and prevalent cohorts with pulmonary arterial hypertension: insight from SERAPHIN. Eur Respir J. 2015 Dec;46(6):1711-20. doi: 10.1183/13993003.00364-2015. Epub 2015 Oct 22.

**PMID:** 26493786

**Citation:** Channick RN, Delcroix M, Ghofrani HA, Hunsche E, Jansa P, Le Brun FO, Mehta S, Pulido T, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Torbicki A, Galie N. Effect of macitentan on hospitalizations: results from the SERAPHIN trial. JACC Heart Fail. 2015 Jan;3(1):1-8. doi: 10.1016/j.jchf.2014.07.013. Epub 2014 Nov 11.

**PMID:** 25457902

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000006976

- Term: Hypertension, Pulmonary

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M2261

- Name: Pulmonary Arterial Hypertension

- Relevance: HIGH

- As Found: Pulmonary Arterial Hypertension

- ID: M10027

- Name: Hypertension, Pulmonary

- Relevance: LOW

- As Found: Unknown

- ID: M30541

- Name: Familial Primary Pulmonary Hypertension

- Relevance: HIGH

- As Found: Pulmonary Arterial Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4807

- Name: Pulmonary Arterial Hypertension

- Relevance: HIGH

- As Found: Pulmonary Arterial Hypertension

### Condition Browse Module - Meshes

- ID: D000081029

- Term: Pulmonary Arterial Hypertension

- ID: D000065627

- Term: Familial Primary Pulmonary Hypertension

- ID: D000006973

- Term: Hypertension

### Intervention Browse Module - Ancestors

- ID: D000065130

- Term: Endothelin A Receptor Antagonists

- ID: D000065128

- Term: Endothelin Receptor Antagonists

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000065131

- Term: Endothelin B Receptor Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M258148

- Name: Macitentan

- Relevance: HIGH

- As Found: Humira

- ID: M30468

- Name: Endothelin A Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M30466

- Name: Endothelin Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000533860

- Term: Macitentan

### Misc Info Module

#### Removed Countries

- Country: Brazil

- Country: Czech Republic

- Country: Denmark

- Country: Finland

- Country: Former Serbia and Montenegro

- Country: Portugal

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation

#### Event Groups

**Group ID:** EG000

**Title:** Placebo

**Description:** Matching ACT-064992 placebo tablet, once daily

**ID:** EG000

**Other Num Affected:** 219

**Other Num at Risk:** 249

**Serious Number Affected:** 137

**Serious Number At Risk:** 249

**Title:** Placebo

**Group ID:** EG001

**Title:** ACT-064992 3 mg

**Description:** ACT-064992 tablet, 3 mg, once daily

**ID:** EG001

**Other Num Affected:** 227

**Other Num at Risk:** 250

**Serious Number Affected:** 130

**Serious Number At Risk:** 250

**Title:** ACT-064992 3 mg

**Group ID:** EG002

**Title:** ACT-064992 10 mg

**Description:** ACT-064992 tablet, 10 mg, once daily

**ID:** EG002

**Other Num Affected:** 222

**Other Num at Risk:** 242

**Serious Number Affected:** 109

**Serious Number At Risk:** 242

**Title:** ACT-064992 10 mg

**Frequency Threshold:** 5

#### Other Events

**Term:** UPPER RESPIRATORY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

**Term:** OEDEMA PERIPHERAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** NASOPHARYNGITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

**Term:** HEADACHE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** PULMONARY ARTERIAL HYPERTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

**Term:** DIZZINESS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** ANAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

**Term:** BRONCHITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

**Term:** COUGH

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

**Term:** DYSPNOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

**Term:** CHEST PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** DIARRHOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** URINARY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

**Term:** INSOMNIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** HYPOKALAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** HYPOTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** RIGHT VENTRICULAR FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** ARTHRALGIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

**Term:** PHARYNGITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

**Term:** PALPITATIONS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** INFLUENZA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

**Term:** BACK PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

**Term:** NAUSEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** RESPIRATORY TRACT INFECTION VIRAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

**Term:** SYNCOPE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** FATIGUE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** VOMITING

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** DYSPEPSIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

**Term:** PAIN IN EXTREMITY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

#### Serious Events

**Term:** PULMONARY ARTERIAL HYPERTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 56

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 48

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 32

**Num At Risk:** 242

**Term:** HAEMOPTYSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 3

**Num At Risk:** 242

**Term:** RESPIRATORY FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 3

**Num At Risk:** 242

**Term:** DYSPNOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** PULMONARY EMBOLISM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** CHRONIC OBSTRUCTIVE PULMONARY DISEASE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ACUTE RESPIRATORY FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** EPISTAXIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** PULMONARY FIBROSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** PLEURAL EFFUSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** HYPOXIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** INTERSTITIAL LUNG DISEASE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** LUNG INFILTRATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** PHARYNGEAL CYST

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** PLEURITIC PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PNEUMONIA ASPIRATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** TACHYPNOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PNEUMOTHORAX

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SLEEP APNOEA SYNDROME

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** RIGHT VENTRICULAR FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 40

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 21

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 23

**Num At Risk:** 242

**Term:** ATRIAL FLUTTER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 4

**Num At Risk:** 242

**Term:** CARDIAC ARREST

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SUPRAVENTRICULAR TACHYCARDIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** ACUTE MYOCARDIAL INFARCTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ATRIAL TACHYCARDIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** BRADYCARDIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** CARDIO-RESPIRATORY ARREST

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ATRIAL FIBRILLATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** LEFT VENTRICULAR FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ACUTE RIGHT VENTRICULAR FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ANGINA PECTORIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CARDIOGENIC SHOCK

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** CORONARY ARTERY DISEASE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ARRHYTHMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ATRIOVENTRICULAR BLOCK

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ATRIOVENTRICULAR BLOCK COMPLETE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PALPITATIONS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** RIGHT VENTRICULAR DYSFUNCTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** TACHYCARDIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** VENTRICULAR TACHYCARDIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ACUTE CORONARY SYNDROME

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ACUTE LEFT VENTRICULAR FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CARDIAC FAILURE CONGESTIVE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CARDIOPULMONARY FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** LEFT VENTRICULAR DYSFUNCTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PERICARDIAL EFFUSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** TACHYARRHYTHMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PNEUMONIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 4

**Num At Risk:** 242

**Term:** GASTROENTERITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** BRONCHITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** UPPER RESPIRATORY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** URINARY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** RESPIRATORY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** LOWER RESPIRATORY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ERYSIPELAS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SEPSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** LUNG INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SEPTIC SHOCK

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** WOUND INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** BACTERIAL SEPSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** BRONCHITIS BACTERIAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** DENGUE FEVER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** DIARRHOEA INFECTIOUS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ENTEROCOCCAL SEPSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HEPATITIS E

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** LOBAR PNEUMONIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** LUNG INFECTION PSEUDOMONAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** NASOPHARYNGITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** OMPHALITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** OVERGROWTH BACTERIAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** PAROTID ABSCESS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** PNEUMONIA INFLUENZAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PNEUMONIA MORAXELLA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PNEUMONIA NECROTISING

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** PNEUMONIA PNEUMOCOCCAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** POST PROCEDURAL CELLULITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PYELONEPHRITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** SALPINGO-OOPHORITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** SIALOADENITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** TRACHEOBRONCHITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** VIRAL INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** VULVAL ABSCESS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** CELLULITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ABSCESS INTESTINAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** APPENDICITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CUTANEOUS TUBERCULOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HERPES ZOSTER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** INFECTED SKIN ULCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SINUSITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PANCREATITIS ACUTE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** UPPER GASTROINTESTINAL HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** DIARRHOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** GASTRIC ULCER HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** HAEMATEMESIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ASCITES

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ABDOMINAL DISTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ABDOMINAL PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ANAL POLYP

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** COLITIS ISCHAEMIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** DYSPHAGIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** GASTROINTESTINAL MOTILITY DISORDER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** GINGIVAL BLEEDING

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** INTESTINAL OBSTRUCTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** MALABSORPTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** NAUSEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** OESOPHAGEAL VARICES HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PANCREATITIS RELAPSING

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** PEPTIC ULCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** TONGUE HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** VOMITING

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ILEUS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** INGUINAL HERNIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PANCREATIC MASS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PERITONITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** RECTAL HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CHEST PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 3

**Num At Risk:** 242

**Term:** SUDDEN DEATH

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** SUDDEN CARDIAC DEATH

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** GENERAL PHYSICAL HEALTH DETERIORATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** PYREXIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ADVERSE DRUG REACTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** DEATH

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** CHEST DISCOMFORT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** DEVICE MALFUNCTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** FATIGUE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** MULTI-ORGAN DISORDER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** MULTI-ORGAN FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** DEVICE DISLOCATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** OEDEMA PERIPHERAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SYNCOPE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 4

**Num At Risk:** 242

**Term:** CARPAL TUNNEL SYNDROME

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HEADACHE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ISCHAEMIC STROKE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** SCIATICA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SUBARACHNOID HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PRESYNCOPE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CEREBRAL INFARCTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CEREBROVASCULAR ACCIDENT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** TRIGEMINAL NEURALGIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ANAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 6

**Num At Risk:** 242

**Term:** THROMBOCYTOPENIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** COAGULOPATHY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HAEMOLYTIC ANAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** HAEMORRHAGIC ANAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** HYPOCOAGULABLE STATE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ANAEMIA MEGALOBLASTIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** COLON CANCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** OVARIAN NEOPLASM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** UTERINE LEIOMYOMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** BREAST CANCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ANGIOSARCOMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** METASTATIC NEOPLASM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** RECTOSIGMOID CANCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** TONGUE NEOPLASM BENIGN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** RECTAL CANCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** MENORRHAGIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** DYSFUNCTIONAL UTERINE BLEEDING

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** OVARIAN CYST

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** METRORRHAGIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PELVIC FLUID COLLECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** POSTMENOPAUSAL HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** VAGINAL HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** UTERINE HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ALANINE AMINOTRANSFERASE INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** ASPARTATE AMINOTRANSFERASE INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** LIVER FUNCTION TEST ABNORMAL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** HEPATIC ENZYME INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** HAEMOGLOBIN DECREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HEPATITIS B VIRUS TEST POSITIVE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** HIV TEST POSITIVE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** INTERNATIONAL NORMALISED RATIO DECREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** TRANSAMINASES INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** GAMMA-GLUTAMYLTRANSFERASE INCREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SUBDURAL HAEMATOMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ANKLE FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** FEMUR FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** LUMBAR VERTEBRAL FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ROAD TRAFFIC ACCIDENT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** THORACIC VERTEBRAL FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** UPPER LIMB FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** BRAIN CONTUSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** BRAIN HERNIATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PATELLA FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** POST PROCEDURAL HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SKULL FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** TRAUMATIC BRAIN INJURY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SYSTEMIC LUPUS ERYTHEMATOSUS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** SYSTEMIC SCLEROSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 242

**Term:** BACK PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** OSTEOARTHRITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** COSTOCHONDRITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** MUSCULOSKELETAL PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ARTHRALGIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** OSTEOPOROTIC FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PAIN IN EXTREMITY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** RENAL FAILURE ACUTE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** GLOMERULONEPHRITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** LUPUS NEPHRITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** NEPHROLITHIASIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** RENAL IMPAIRMENT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** TUBULOINTERSTITIAL NEPHRITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CALCULUS URINARY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PROTEINURIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** RENAL COLIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** RENAL FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CHOLECYSTITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** CHOLELITHIASIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** HEPATITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** JAUNDICE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** BILIARY COLIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CHOLANGITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ISCHAEMIC HEPATITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** LIVER INJURY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HEPATIC CIRRHOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** POST CHOLECYSTECTOMY SYNDROME

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PREGNANCY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** COMPLICATION OF PREGNANCY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HYPOTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** HYPOVOLAEMIC SHOCK

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ARTERIOVENOUS FISTULA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ORTHOSTATIC HYPOTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ARTERIAL THROMBOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CIRCULATORY COLLAPSE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HYPERTENSIVE CRISIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** VASCULITIS NECROTISING

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** DEHYDRATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HYPONATRAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ELECTROLYTE IMBALANCE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** FLUID OVERLOAD

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HYPERGLYCAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HYPOGLYCAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** DIABETES MELLITUS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** DIABETIC KETOACIDOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** GOUT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HYPERURICAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** TYPE 2 DIABETES MELLITUS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** CONFUSIONAL STATE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ALCOHOLISM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** MENTAL DISORDER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** MENTAL STATUS CHANGES

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** DRUG ABUSE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** SKIN ULCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** ECZEMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** LEUKOCYTOCLASTIC VASCULITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** PURPURA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HIP ARTHROPLASTY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** CARDIAC PACEMAKER INSERTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** HEART AND LUNG TRANSPLANT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** TOOTH EXTRACTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** GLYCOGEN STORAGE DISEASE TYPE V

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 250

**Group ID:** EG002

**Num At Risk:** 242

**Term:** ADRENAL INSUFFICIENCY

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Term:** GLAUCOMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 14.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 249

**Group ID:** EG001

**Num At Risk:** 250

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 242

**Time Frame:** Up to end of treatment plus 28 days (Up to approximately 36 months)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 250

**Group ID:** BG001

**Value:** 250

**Group ID:** BG002

**Value:** 242

**Group ID:** BG003

**Value:** 742

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo

**Description:** Matching ACT-064992 placebo tablet, once daily

### Group

**ID:** BG001

**Title:** ACT-064992 3 mg

**Description:** ACT-064992 tablet, 3 mg, once daily

### Group

**ID:** BG002

**Title:** ACT-064992 10 mg

**Description:** ACT-064992 tablet, 10 mg, once daily

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 20

**Class Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 199

#### Measurement

**Group ID:** BG001

**Value:** 208

#### Measurement

**Group ID:** BG002

**Value:** 209

#### Measurement

**Group ID:** BG003

**Value:** 616

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

#### Measurement

**Group ID:** BG000

**Value:** 43

#### Measurement

**Group ID:** BG001

**Value:** 33

#### Measurement

**Group ID:** BG002

**Value:** 27

#### Measurement

**Group ID:** BG003

**Value:** 103

**Class Title:** >=65 years

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 17.03

**Value:** 46.7

#### Measurement

**Group ID:** BG001

**Spread:** 16.26

**Value:** 44.5

#### Measurement

**Group ID:** BG002

**Spread:** 14.99

**Value:** 45.5

#### Measurement

**Group ID:** BG003

**Spread:** 16.13

**Value:** 45.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 184

#### Measurement

**Group ID:** BG001

**Value:** 187

#### Measurement

**Group ID:** BG002

**Value:** 194

#### Measurement

**Group ID:** BG003

**Value:** 565

**Class Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 65

#### Measurement

**Group ID:** BG001

**Value:** 61

#### Measurement

**Group ID:** BG002

**Value:** 48

#### Measurement

**Group ID:** BG003

**Value:** 174

**Class Title:** Male

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 13

#### Measurement

**Group ID:** BG003

**Value:** 43

**Class Title:** Argentina

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 10

**Class Title:** Australia

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 4

**Class Title:** Austria

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 23

**Class Title:** Belarus

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

**Class Title:** Belgium

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 6

**Class Title:** Bulgaria

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 16

**Class Title:** Canada

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 9

#### Measurement

**Group ID:** BG003

**Value:** 28

**Class Title:** Chile

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Measurement

**Group ID:** BG001

**Value:** 29

#### Measurement

**Group ID:** BG002

**Value:** 27

#### Measurement

**Group ID:** BG003

**Value:** 87

**Class Title:** China

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 9

**Class Title:** Colombia

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 1

**Class Title:** Croatia

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Class Title:** Denmark

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 11

**Class Title:** France

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 13

#### Measurement

**Group ID:** BG003

**Value:** 44

**Class Title:** Germany

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 4

**Class Title:** Hong Kong

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 6

**Class Title:** Hungary

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 15

#### Measurement

**Group ID:** BG003

**Value:** 47

**Class Title:** India

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 20

**Class Title:** Israel

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 5

**Class Title:** Italy

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 7

**Class Title:** Malaysia

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 14

#### Measurement

**Group ID:** BG003

**Value:** 40

**Class Title:** Mexico

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Class Title:** Netherlands

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

**Class Title:** Norway

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 7

**Class Title:** Peru

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 7

#### Measurement

**Group ID:** BG003

**Value:** 21

**Class Title:** Poland

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 16

**Class Title:** Romania

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 23

#### Measurement

**Group ID:** BG003

**Value:** 72

**Class Title:** Russian Federation

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 16

**Class Title:** Serbia

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 13

**Class Title:** Singapore

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 6

**Class Title:** Slovakia

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 24

**Class Title:** South Africa

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 15

**Class Title:** Spain

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 7

**Class Title:** Sweden

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 14

**Class Title:** Taiwan

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 9

#### Measurement

**Group ID:** BG003

**Value:** 25

**Class Title:** Thailand

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 3

**Class Title:** Turkey

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 5

**Class Title:** United Kingdom

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 19

#### Measurement

**Group ID:** BG003

**Value:** 67

**Class Title:** United States

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 14

**Class Title:** Ukraine

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 1

**Class Title:** Class I

#### Measurement

**Group ID:** BG000

**Value:** 129

#### Measurement

**Group ID:** BG001

**Value:** 138

#### Measurement

**Group ID:** BG002

**Value:** 120

#### Measurement

**Group ID:** BG003

**Value:** 387

**Class Title:** Class II

#### Measurement

**Group ID:** BG000

**Value:** 116

#### Measurement

**Group ID:** BG001

**Value:** 105

#### Measurement

**Group ID:** BG002

**Value:** 116

#### Measurement

**Group ID:** BG003

**Value:** 337

**Class Title:** Class III

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 14

**Class Title:** Class IV

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** NUMBER
**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:** NUMBER
**Title:** Gender
**Unit of Measure:** participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Description:** Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope.

Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope.

Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope.

Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA.
**Parameter Type:** NUMBER
**Title:** World Health Organisation Functional Class
**Unit of Measure:** participants
**Population Description:** For the baseline measures of age, gender, and World Health Organization (WHO) functional class, data were missing for 1 patient in the placebo group and for 2 patients in the 3 mg macitentan group.
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** parisa.danaietash@actelion.com
**Organization:** Actelion Pharmaceuticals Ltd
**Title:** Parisa Danaietash
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.516
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 97.5
**CI Upper Limit:** 0.960
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0108
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.704
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.392
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 97.5
**CI Upper Limit:** 0.762
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.547
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.462
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 97.5
**CI Upper Limit:** 0.970
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0146
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.669
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.335
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 97.5
**CI Upper Limit:** 0.747
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.500
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 0.477
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 97.5
**CI Upper Limit:** 1.976
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.9249
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.971
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.287
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 97.5
**CI Upper Limit:** 1.418
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2037
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.638
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 0.653
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 97.5
**CI Upper Limit:** 1.673
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.8312
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 1.046
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.464
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 97.5
**CI Upper Limit:** 1.282
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2509
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.771
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 92.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 79.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 65.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 74.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63.2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 90.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 76.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 62.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 77.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70.6
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 97.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 97.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 92.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 91.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 91.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 87.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93.3
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 91.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 91.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 87.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 87.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 83.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 86.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82.9
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 110.6
- **Upper Limit:** 
- **Value:** 352
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 95.5
- **Upper Limit:** 
- **Value:** 364
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 93.2
- **Upper Limit:** 
- **Value:** 363
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 100.59
- **Upper Limit:** 
- **Value:** -9.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 93.15
- **Upper Limit:** 
- **Value:** 7.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 83.54
- **Upper Limit:** 
- **Value:** 12.5
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 259
- **Spread:** 587
- **Upper Limit:** 3390
- **Value:** 886
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 250
- **Spread:** 541
- **Upper Limit:** 2317
- **Value:** 945
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 254
- **Spread:** 550
- **Upper Limit:** 2279
- **Value:** 907
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 164
- **Spread:** 656
- **Upper Limit:** 3409
- **Value:** 1042
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 71
- **Spread:** 434
- **Upper Limit:** 2308
- **Value:** 736
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 158
- **Spread:** 497
- **Upper Limit:** 2813
- **Value:** 680
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.31
- **Spread:** 
- **Upper Limit:** 4.54
- **Value:** 2.54
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.13
- **Spread:** 
- **Upper Limit:** 5.15
- **Value:** 2.34
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 1.20
- **Spread:** 
- **Upper Limit:** 6.24
- **Value:** 2.63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.06
- **Spread:** 
- **Upper Limit:** 3.89
- **Value:** 2.21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.26
- **Spread:** 
- **Upper Limit:** 5.59
- **Value:** 2.69
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 1.46
- **Spread:** 
- **Upper Limit:** 5.11
- **Value:** 2.93
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.53
- **Spread:** 
- **Upper Limit:** 0.44
- **Value:** -0.33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.81
- **Spread:** 
- **Upper Limit:** 1.76
- **Value:** 0.36
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -2.97
- **Spread:** 
- **Upper Limit:** 1.99
- **Value:** 0.30
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).

Other worsening of PAH was defined by the combined occurrence of all the following 3 events:

At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.

AND worsening of PAH symptoms including at least one of the following:

a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy

AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics
**Parameter Type:** NUMBER
**Population Description:** All randomized patients
**Reporting Status:** POSTED
**Time Frame:** Up to end of treatment (data presented up to month 36)
**Title:** Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants-Kaplan Meier
##### Group
**Description:** Matching ACT-064992 placebo tablet, once daily
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** ACT-064992 tablet, 3 mg, once daily
**ID:** OG001
**Title:** ACT-064992 3 mg
##### Group
**Description:** ACT-064992 tablet, 10 mg, once daily
**ID:** OG002
**Title:** ACT-064992 10 mg
#### Outcome Measure 2
**Description:** Events of PAH or hospitalization for PAH up to the end of treatment included: death due to PAH, or onset of a treatment-emergent adverse event with a fatal outcome due to PAH occurring up to 4 weeks after the end of treatment, or hospitalisation for PAH up to the end of treatment.
**Parameter Type:** NUMBER
**Population Description:** All randomized patients
**Reporting Status:** POSTED
**Time Frame:** Up to end of treatment (data presented up to month 36)
**Title:** Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants-Kaplan Meier
##### Group
**Description:** Matching ACT-064992 placebo tablet, once daily
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** ACT-064992 tablet, 3 mg, once daily
**ID:** OG001
**Title:** ACT-064992 3 mg
##### Group
**Description:** ACT-064992 tablet, 10 mg, once daily
**ID:** OG002
**Title:** ACT-064992 10 mg
#### Outcome Measure 3
**Description:** Events of death due to any cause up to the end of treatment (plus 7 days)
**Parameter Type:** NUMBER
**Population Description:** All randomized patients
**Reporting Status:** POSTED
**Time Frame:** Up to end of treatment (data presented up to month 36)
**Title:** Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants-Kaplan Meier
##### Group
**Description:** Matching ACT-064992 placebo tablet, once daily
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** ACT-064992 tablet, 3 mg, once daily
**ID:** OG001
**Title:** ACT-064992 3 mg
##### Group
**Description:** ACT-064992 tablet, 10 mg, once daily
**ID:** OG002
**Title:** ACT-064992 10 mg
#### Outcome Measure 4
**Description:** Events of death due to any cause up to the end of study (EOS). The initiation of EOS procedure occurred when the target of 285 events was expected to have been achieved (30 January 2012).
**Parameter Type:** NUMBER
**Population Description:** All randomized patients
**Reporting Status:** POSTED
**Time Frame:** Up to end of study (data presented up to month 36)
**Title:** Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants-Kaplan Meier
##### Group
**Description:** Matching ACT-064992 placebo tablet, once daily
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** ACT-064992 tablet, 3 mg, once daily
**ID:** OG001
**Title:** ACT-064992 3 mg
##### Group
**Description:** ACT-064992 tablet, 10 mg, once daily
**ID:** OG002
**Title:** ACT-064992 10 mg
#### Outcome Measure 5
**Description:** The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis
**Reporting Status:** POSTED
**Time Frame:** Baseline to month 6
**Title:** Change From Baseline to Month 6 in 6-minute Walk Distance
**Type:** SECONDARY
**Unit of Measure:** metres
##### Group
**Description:** Matching ACT-064992 placebo tablet, once daily
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** ACT-064992 tablet, 3 mg, once daily
**ID:** OG001
**Title:** ACT-064992 3 mg
##### Group
**Description:** ACT-064992 tablet, 10 mg, once daily
**ID:** OG002
**Title:** ACT-064992 10 mg
#### Outcome Measure 6
**Description:** Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope.

Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope.

Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope.

Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA.
**Parameter Type:** NUMBER
**Population Description:** All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis
**Reporting Status:** POSTED
**Time Frame:** Baseline to month 6
**Title:** Number of Patients With Improvements in World Health Organization Functional Class From Baseline to Month 6
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Matching ACT-064992 placebo tablet, once daily
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** ACT-064992 tablet, 3 mg, once daily
**ID:** OG001
**Title:** ACT-064992 3 mg
##### Group
**Description:** ACT-064992 tablet, 10 mg, once daily
**ID:** OG002
**Title:** ACT-064992 10 mg
#### Outcome Measure 7
**Description:** In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study
**Reporting Status:** POSTED
**Time Frame:** Baseline to month 6
**Title:** Pulmonary Vascular Resistance at Baseline and Month 6
**Type:** SECONDARY
**Unit of Measure:** (dyn*sec/cm^5)
##### Group
**Description:** Matching ACT-064992 placebo tablet, once daily
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** ACT-064992 tablet, 3 mg, once daily
**ID:** OG001
**Title:** ACT-064992 3 mg
##### Group
**Description:** ACT-064992 tablet, 10 mg, once daily
**ID:** OG002
**Title:** ACT-064992 10 mg
#### Outcome Measure 8
**Description:** In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study
**Reporting Status:** POSTED
**Time Frame:** Baseline to month 6
**Title:** Cardiac Index at Baseline and Month 6
**Type:** SECONDARY
**Unit of Measure:** L/min/m^2
##### Group
**Description:** Matching ACT-064992 placebo tablet, once daily
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** ACT-064992 tablet, 3 mg, once daily
**ID:** OG001
**Title:** ACT-064992 3 mg
##### Group
**Description:** ACT-064992 tablet, 10 mg, once daily
**ID:** OG002
**Title:** ACT-064992 10 mg
#### Outcome Measure 9
**Description:** Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).

Other worsening of PAH was defined by the combined occurrence of all the following 3 events:

At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.

AND worsening of PAH symptoms including at least one of the following:

a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy

AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics
**Parameter Type:** NUMBER
**Population Description:** All randomized patients
**Reporting Status:** POSTED
**Time Frame:** Up to end of treatment (Up to 36 months)
**Title:** Summary of the First Causes of Morbidity or Mortality
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** participants
##### Group
**Description:** Matching ACT-064992 placebo tablet, once daily
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** ACT-064992 tablet, 3 mg, once daily
**ID:** OG001
**Title:** ACT-064992 3 mg
##### Group
**Description:** ACT-064992 tablet, 10 mg, once daily
**ID:** OG002
**Title:** ACT-064992 10 mg
### Participant Flow Module
#### Group
**Description:** Matching ACT-064992 placebo tablet, once daily
**ID:** FG000
**Title:** Placebo
#### Group
**Description:** ACT-064992 tablet, 3 mg, once daily
**ID:** FG001
**Title:** ACT-064992 3 mg
#### Group
**Description:** ACT-064992 tablet, 10 mg, once daily
**ID:** FG002
**Title:** ACT-064992 10 mg
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 44
###### Reason
**Group ID:** FG001
**Number of Subjects:** 47
###### Reason
**Group ID:** FG002
**Number of Subjects:** 34
##### Withdraw
**Type:** Withdrawal of consent
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
###### Reason
**Group ID:** FG002
**Number of Subjects:** 4
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Administrative reason
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Incorrect randomization
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 250
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 250
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 242
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 194
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 192
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 201
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 56
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 58
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 41
**Recruitment Details:** A total of 955 patients were screened from 158 centers in 39 countries, and 742 patients from 151 centers in 39 countries were randomized
**Has Results:** True