## Protocol Section
### Identification Module
**NCT ID:** NCT02117479

**Brief Title:** Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

**Official Title:** A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor, Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 1 Study)

#### Organization Study ID Info
**ID:** INCB 18424-362
#### Organization
**Class:** INDUSTRY
**Full Name:** Incyte Corporation
### Status Module
#### Completion Date
**Date:** 2016-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-26

**Type:** ACTUAL

**Last Update Submit Date:** 2019-03-14

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2016-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-07-11

**Type:** ACTUAL

**Results First Submit Date:** 2017-02-09

**Results First Submit QC Date:** 2017-06-09

#### Start Date
**Date:** 2014-03

**Type:** ACTUAL

**Status Verified Date:** 2019-03

#### Study First Post Date
**Date:** 2014-04-21
**Type:** ESTIMATED
**Study First Submit Date:** 2014-04-16
**Study First Submit QC Date:** 2014-04-17
**Why Stopped:** The study was terminated early based on the results of the planned interim analysis.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Incyte Corporation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

**Detailed Description:** This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment groups:

* Treatment A (N = 155): Capecitabine + ruxolitinib
* Treatment B (N = 155): Capecitabine + placebo

Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered daily for each cycle. Treatment for all participants continued as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued study treatment before study termination were monitored for safety up to 30-35 days from the end of treatment. All participants were followed for survival until study termination or the safety follow-up visit.

### Conditions Module

**Conditions:**

- Pancreatic Cancer

**Keywords:**

- Metastatic pancreatic cancer

- Metastatic pancreatic adenocarcinoma that is recurrent

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 321

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Ruxolitinib

- Drug: Capecitabine

**Label:** Ruxolitinib plus capecitabine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo

- Drug: Capecitabine

**Label:** Placebo plus capecitabine

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ruxolitinib plus capecitabine

**Description:** 5 mg tablets to be administered by mouth twice daily (BID)

**Name:** Ruxolitinib

**Other Names:**

- Jakafi ®

- Jakavi ®

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo plus capecitabine

**Description:** 5 mg tablets to be administered by mouth twice daily (BID)

**Name:** Placebo

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo plus capecitabine

- Ruxolitinib plus capecitabine

**Description:** 150 and 500 mg tablets to be administered by mouth twice daily (BID)

**Name:** Capecitabine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.

**Measure:** Overall Survival (OS)

**Time Frame:** Randomization until death due to any cause; up to the data cutoff 11FEB2016.

#### Secondary Outcomes

**Description:** Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.

**Measure:** Progression-free Survival (PFS)

**Time Frame:** Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.

**Description:** PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.

**Measure:** Percentage of Participants Achieving Progression Free Survival (PFS)

**Time Frame:** Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.

**Description:** Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.

**Measure:** Objective Response Rate (ORR)

**Time Frame:** Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.

**Description:** Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.

**Measure:** Duration of Response

**Time Frame:** Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.

**Description:** A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).

**Measure:** Participants With Treatment-Emergent Adverse Events (TEAEs)

**Time Frame:** Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the pancreas.
* Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
* ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
* Radiographically measurable or evaluable disease
* Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

  1. mGPS of 1: C-reactive protein \>10 mg/L and albumin ≥35 g/L
  2. mGPS of 2: C-reactive protein \>10 mg/L and albumin \<35 g/L

Exclusion Criteria:

* Received more than 1 prior regimen for advanced or metastatic disease.
* Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
* Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
* Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
* Prior treatment with a JAK inhibitor for any indication.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Avondale

**Country:** United States

**State:** Arizona

**Location 2:**

**City:** Chandler

**Country:** United States

**State:** Arizona

**Location 3:**

**City:** Gilbert

**Country:** United States

**State:** Arizona

**Location 4:**

**City:** Glendale

**Country:** United States

**State:** Arizona

**Location 5:**

**City:** Mesa

**Country:** United States

**State:** Arizona

**Location 6:**

**City:** Phoenix

**Country:** United States

**State:** Arizona

**Location 7:**

**City:** Scottsdale

**Country:** United States

**State:** Arizona

**Location 8:**

**City:** Surprise

**Country:** United States

**State:** Arizona

**Location 9:**

**City:** Tucson

**Country:** United States

**State:** Arizona

**Location 10:**

**City:** Hot Springs

**Country:** United States

**State:** Arkansas

**Location 11:**

**City:** Jonesboro

**Country:** United States

**State:** Arkansas

**Location 12:**

**City:** Anaheim

**Country:** United States

**State:** California

**Location 13:**

**City:** Bakersfield

**Country:** United States

**State:** California

**Location 14:**

**City:** Berkeley

**Country:** United States

**State:** California

**Location 15:**

**City:** Beverly Hills

**Country:** United States

**State:** California

**Location 16:**

**City:** Chula Vista

**Country:** United States

**State:** California

**Location 17:**

**City:** Covina

**Country:** United States

**State:** California

**Location 18:**

**City:** Downey

**Country:** United States

**State:** California

**Location 19:**

**City:** El Cajon

**Country:** United States

**State:** California

**Location 20:**

**City:** Fullerton

**Country:** United States

**State:** California

**Location 21:**

**City:** Gilroy

**Country:** United States

**State:** California

**Location 22:**

**City:** Glendale

**Country:** United States

**State:** California

**Location 23:**

**City:** La Mesa

**Country:** United States

**State:** California

**Location 24:**

**City:** Long Beach

**Country:** United States

**State:** California

**Location 25:**

**City:** Los Angeles

**Country:** United States

**State:** California

**Location 26:**

**City:** Lynwood

**Country:** United States

**State:** California

**Location 27:**

**City:** Modesto

**Country:** United States

**State:** California

**Location 28:**

**City:** Montebello

**Country:** United States

**State:** California

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**City:** Northridge

**Country:** United States

**State:** California

**Location 30:**

**City:** Oceanside

**Country:** United States

**State:** California

**Location 31:**

**City:** Orange

**Country:** United States

**State:** California

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**City:** Redondo Beach

**Country:** United States

**State:** California

**Location 33:**

**City:** San Diego

**Country:** United States

**State:** California

**Location 34:**

**City:** San Francisco

**Country:** United States

**State:** California

**Location 35:**

**City:** San Luis Obispo

**Country:** United States

**State:** California

**Location 36:**

**City:** Santa Ana

**Country:** United States

**State:** California

**Location 37:**

**City:** Santa Maria

**Country:** United States

**State:** California

**Location 38:**

**City:** Santa Monica

**Country:** United States

**State:** California

**Location 39:**

**City:** Torrance

**Country:** United States

**State:** California

**Location 40:**

**City:** Whittier

**Country:** United States

**State:** California

**Location 41:**

**City:** Aurora

**Country:** United States

**State:** Colorado

**Location 42:**

**City:** Boulder

**Country:** United States

**State:** Colorado

**Location 43:**

**City:** Colorado Springs

**Country:** United States

**State:** Colorado

**Location 44:**

**City:** Denver

**Country:** United States

**State:** Colorado

**Location 45:**

**City:** Grand Junction

**Country:** United States

**State:** Colorado

**Location 46:**

**City:** Longmont

**Country:** United States

**State:** Colorado

**Location 47:**

**City:** Thornton

**Country:** United States

**State:** Colorado

**Location 48:**

**City:** New Britain

**Country:** United States

**State:** Connecticut

**Location 49:**

**City:** New Haven

**Country:** United States

**State:** Connecticut

**Location 50:**

**City:** Southington

**Country:** United States

**State:** Connecticut

**Location 51:**

**City:** Trumbull

**Country:** United States

**State:** Connecticut

**Location 52:**

**City:** Newark

**Country:** United States

**State:** Delaware

**Location 53:**

**City:** Boca Raton

**Country:** United States

**State:** Florida

**Location 54:**

**City:** Hollywood

**Country:** United States

**State:** Florida

**Location 55:**

**City:** Miami

**Country:** United States

**State:** Florida

**Location 56:**

**City:** Pembroke Pines

**Country:** United States

**State:** Florida

**Location 57:**

**City:** Atlanta

**Country:** United States

**State:** Georgia

**Location 58:**

**City:** Austell

**Country:** United States

**State:** Georgia

**Location 59:**

**City:** Carrollton

**Country:** United States

**State:** Georgia

**Location 60:**

**City:** Cartersville

**Country:** United States

**State:** Georgia

**Location 61:**

**City:** Douglasville

**Country:** United States

**State:** Georgia

**Location 62:**

**City:** Marietta

**Country:** United States

**State:** Georgia

**Location 63:**

**City:** Newnan

**Country:** United States

**State:** Georgia

**Location 64:**

**City:** Rome

**Country:** United States

**State:** Georgia

**Location 65:**

**City:** Thomasville

**Country:** United States

**State:** Georgia

**Location 66:**

**City:** Arlington Heights

**Country:** United States

**State:** Illinois

**Location 67:**

**City:** Chicago

**Country:** United States

**State:** Illinois

**Location 68:**

**City:** Hinsdale

**Country:** United States

**State:** Illinois

**Location 69:**

**City:** Niles

**Country:** United States

**State:** Illinois

**Location 70:**

**City:** Urbana

**Country:** United States

**State:** Illinois

**Location 71:**

**City:** Goshen

**Country:** United States

**State:** Indiana

**Location 72:**

**City:** Indianapolis

**Country:** United States

**State:** Indiana

**Location 73:**

**City:** Topeka

**Country:** United States

**State:** Kansas

**Location 74:**

**City:** Ashland

**Country:** United States

**State:** Kentucky

**Location 75:**

**City:** Louisville

**Country:** United States

**State:** Kentucky

**Location 76:**

**City:** Metairie

**Country:** United States

**State:** Louisiana

**Location 77:**

**City:** New Orleans

**Country:** United States

**State:** Louisiana

**Location 78:**

**City:** Scarborough

**Country:** United States

**State:** Maine

**Location 79:**

**City:** Annapolis

**Country:** United States

**State:** Maryland

**Location 80:**

**City:** Baltimore

**Country:** United States

**State:** Maryland

**Location 81:**

**City:** Bethesda

**Country:** United States

**State:** Maryland

**Location 82:**

**City:** Rockville

**Country:** United States

**State:** Maryland

**Location 83:**

**City:** Worcester

**Country:** United States

**State:** Massachusetts

**Location 84:**

**City:** Ann Arbor

**Country:** United States

**State:** Michigan

**Location 85:**

**City:** Detroit

**Country:** United States

**State:** Michigan

**Location 86:**

**City:** Kalamazoo

**Country:** United States

**State:** Michigan

**Location 87:**

**City:** Lansing

**Country:** United States

**State:** Michigan

**Location 88:**

**City:** Woodbury

**Country:** United States

**State:** Minnesota

**Location 89:**

**City:** Bolivar

**Country:** United States

**State:** Missouri

**Location 90:**

**City:** Kansas City

**Country:** United States

**State:** Missouri

**Location 91:**

**City:** Saint Louis

**Country:** United States

**State:** Missouri

**Location 92:**

**City:** Kalispell

**Country:** United States

**State:** Montana

**Location 93:**

**City:** Hastings

**Country:** United States

**State:** Nebraska

**Location 94:**

**City:** Omaha

**Country:** United States

**State:** Nebraska

**Location 95:**

**City:** Papillion

**Country:** United States

**State:** Nebraska

**Location 96:**

**City:** Las Vegas

**Country:** United States

**State:** Nevada

**Location 97:**

**City:** Lebanon

**Country:** United States

**State:** New Hampshire

**Location 98:**

**City:** East Orange

**Country:** United States

**State:** New Jersey

**Location 99:**

**City:** Farmington

**Country:** United States

**State:** New Mexico

**Location 100:**

**City:** Binghamton

**Country:** United States

**State:** New York

**Location 101:**

**City:** Bronx

**Country:** United States

**State:** New York

**Location 102:**

**City:** Fresh Meadows

**Country:** United States

**State:** New York

**Location 103:**

**City:** Hudson

**Country:** United States

**State:** New York

**Location 104:**

**City:** Johnson City

**Country:** United States

**State:** New York

**Location 105:**

**City:** New York

**Country:** United States

**State:** New York

**Location 106:**

**City:** Nyack

**Country:** United States

**State:** New York

**Location 107:**

**City:** Rochester

**Country:** United States

**State:** New York

**Location 108:**

**City:** Durham

**Country:** United States

**State:** North Carolina

**Location 109:**

**City:** Wake Forest

**Country:** United States

**State:** North Carolina

**Location 110:**

**City:** Winston-Salem

**Country:** United States

**State:** North Carolina

**Location 111:**

**City:** Canton

**Country:** United States

**State:** Ohio

**Location 112:**

**City:** Columbus

**Country:** United States

**State:** Ohio

**Location 113:**

**City:** Middletown

**Country:** United States

**State:** Ohio

**Location 114:**

**City:** Oregon

**Country:** United States

**State:** Ohio

**Location 115:**

**City:** Toledo

**Country:** United States

**State:** Ohio

**Location 116:**

**City:** Eugene

**Country:** United States

**State:** Oregon

**Location 117:**

**City:** Portland

**Country:** United States

**State:** Oregon

**Location 118:**

**City:** Springfield

**Country:** United States

**State:** Oregon

**Location 119:**

**City:** Tualatin

**Country:** United States

**State:** Oregon

**Location 120:**

**City:** Philadelphia

**Country:** United States

**State:** Pennsylvania

**Location 121:**

**City:** Charleston

**Country:** United States

**State:** South Carolina

**Location 122:**

**City:** Seneca

**Country:** United States

**State:** South Carolina

**Location 123:**

**City:** Spartanburg

**Country:** United States

**State:** South Carolina

**Location 124:**

**City:** Chattanooga

**Country:** United States

**State:** Tennessee

**Location 125:**

**City:** Knoxville

**Country:** United States

**State:** Tennessee

**Location 126:**

**City:** Memphis

**Country:** United States

**State:** Tennessee

**Location 127:**

**City:** Nashville

**Country:** United States

**State:** Tennessee

**Location 128:**

**City:** Arlington

**Country:** United States

**State:** Texas

**Location 129:**

**City:** Austin

**Country:** United States

**State:** Texas

**Location 130:**

**City:** Beaumont

**Country:** United States

**State:** Texas

**Location 131:**

**City:** Bedford

**Country:** United States

**State:** Texas

**Location 132:**

**City:** Cedar Park

**Country:** United States

**State:** Texas

**Location 133:**

**City:** Dallas

**Country:** United States

**State:** Texas

**Location 134:**

**City:** Denton

**Country:** United States

**State:** Texas

**Location 135:**

**City:** El Paso

**Country:** United States

**State:** Texas

**Location 136:**

**City:** Fort Worth

**Country:** United States

**State:** Texas

**Location 137:**

**City:** Houston

**Country:** United States

**State:** Texas

**Location 138:**

**City:** Plano

**Country:** United States

**State:** Texas

**Location 139:**

**City:** Round Rock

**Country:** United States

**State:** Texas

**Location 140:**

**City:** San Antonio

**Country:** United States

**State:** Texas

**Location 141:**

**City:** Temple

**Country:** United States

**State:** Texas

**Location 142:**

**City:** Tyler

**Country:** United States

**State:** Texas

**Location 143:**

**City:** Waco

**Country:** United States

**State:** Texas

**Location 144:**

**City:** Ogden

**Country:** United States

**State:** Utah

**Location 145:**

**City:** Salt Lake City

**Country:** United States

**State:** Utah

**Location 146:**

**City:** Blacksburg

**Country:** United States

**State:** Virginia

**Location 147:**

**City:** Richmond

**Country:** United States

**State:** Virginia

**Location 148:**

**City:** Roanoke

**Country:** United States

**State:** Virginia

**Location 149:**

**City:** Salem

**Country:** United States

**State:** Virginia

**Location 150:**

**City:** Wytheville

**Country:** United States

**State:** Virginia

**Location 151:**

**City:** Seattle

**Country:** United States

**State:** Washington

**Location 152:**

**City:** Vancouver

**Country:** United States

**State:** Washington

**Location 153:**

**City:** Madison

**Country:** United States

**State:** Wisconsin

**Location 154:**

**City:** Australian Capital Territory

**Country:** Australia

**Location 155:**

**City:** New South Wales

**Country:** Australia

**Location 156:**

**City:** South Australia

**Country:** Australia

**Location 157:**

**City:** Victoria

**Country:** Australia

**Location 158:**

**City:** Aalst

**Country:** Belgium

**Location 159:**

**City:** Brugge

**Country:** Belgium

**Location 160:**

**City:** Bruxelles

**Country:** Belgium

**Location 161:**

**City:** Edegem

**Country:** Belgium

**Location 162:**

**City:** Gent

**Country:** Belgium

**Location 163:**

**City:** Gilly

**Country:** Belgium

**Location 164:**

**City:** Kortrijk

**Country:** Belgium

**Location 165:**

**City:** Leuven

**Country:** Belgium

**Location 166:**

**City:** Calgary

**Country:** Canada

**State:** Alberta

**Location 167:**

**City:** Oshawa

**Country:** Canada

**State:** Ontario

**Location 168:**

**City:** Sault Ste. Marie

**Country:** Canada

**State:** Ontario

**Location 169:**

**City:** Toronto

**Country:** Canada

**State:** Ontario

**Location 170:**

**City:** Greenfield Park

**Country:** Canada

**State:** Quebec

**Location 171:**

**City:** Laval

**Country:** Canada

**State:** Quebec

**Location 172:**

**City:** Montreal

**Country:** Canada

**State:** Quebec

**Location 173:**

**City:** Aschaffenburg

**Country:** Germany

**Location 174:**

**City:** Berlin

**Country:** Germany

**Location 175:**

**City:** Bochum

**Country:** Germany

**Location 176:**

**City:** Essen

**Country:** Germany

**Location 177:**

**City:** Frankford

**Country:** Germany

**Location 178:**

**City:** Koeln

**Country:** Germany

**Location 179:**

**City:** Velbert

**Country:** Germany

**Location 180:**

**City:** Aviano

**Country:** Italy

**Location 181:**

**City:** Bari

**Country:** Italy

**Location 182:**

**City:** Bergamo

**Country:** Italy

**Location 183:**

**City:** Brescia

**Country:** Italy

**Location 184:**

**City:** Cremona

**Country:** Italy

**Location 185:**

**City:** Firenze

**Country:** Italy

**Location 186:**

**City:** Genova

**Country:** Italy

**Location 187:**

**City:** Lido di Camaiore

**Country:** Italy

**Location 188:**

**City:** Milano

**Country:** Italy

**Location 189:**

**City:** Napoli

**Country:** Italy

**Location 190:**

**City:** Pisa

**Country:** Italy

**Location 191:**

**City:** Rimini

**Country:** Italy

**Location 192:**

**City:** Roma

**Country:** Italy

**Location 193:**

**City:** Hwasun-gun

**Country:** Korea, Republic of

**Location 194:**

**City:** Seongnam-si

**Country:** Korea, Republic of

**Location 195:**

**City:** Seoul

**Country:** Korea, Republic of

**Location 196:**

**City:** Auckland

**Country:** New Zealand

**Location 197:**

**City:** Christchurch

**Country:** New Zealand

**Location 198:**

**City:** Hamilton

**Country:** New Zealand

**Location 199:**

**City:** Badajoz

**Country:** Spain

**Location 200:**

**City:** Barcelona

**Country:** Spain

**Location 201:**

**City:** Madrid

**Country:** Spain

**Location 202:**

**City:** Malaga

**Country:** Spain

**Location 203:**

**City:** Seville

**Country:** Spain

**Location 204:**

**City:** Taichung

**Country:** Taiwan

**Location 205:**

**City:** Tainan

**Country:** Taiwan

**Location 206:**

**City:** Taipei

**Country:** Taiwan

**Location 207:**

**City:** Patumwan

**Country:** Thailand

**Location 208:**

**City:** Ratchathewi

**Country:** Thailand

**Location 209:**

**City:** Seetatarom

**Country:** Thailand

**Location 210:**

**City:** Aberdeen

**Country:** United Kingdom

**Location 211:**

**City:** Bangor

**Country:** United Kingdom

**Location 212:**

**City:** Birmingham

**Country:** United Kingdom

**Location 213:**

**City:** Boston

**Country:** United Kingdom

**Location 214:**

**City:** Bristol

**Country:** United Kingdom

**Location 215:**

**City:** Cardiff

**Country:** United Kingdom

**Location 216:**

**City:** Glasgow

**Country:** United Kingdom

**Location 217:**

**City:** Guildford

**Country:** United Kingdom

**Location 218:**

**City:** Harlow

**Country:** United Kingdom

**Location 219:**

**City:** Huddersfield

**Country:** United Kingdom

**Location 220:**

**City:** Lancaster

**Country:** United Kingdom

**Location 221:**

**City:** Leeds

**Country:** United Kingdom

**Location 222:**

**City:** London

**Country:** United Kingdom

**Location 223:**

**City:** Manchester

**Country:** United Kingdom

**Location 224:**

**City:** Newcastle upon Tyne

**Country:** United Kingdom

**Location 225:**

**City:** Nottingham

**Country:** United Kingdom

**Location 226:**

**City:** Plymouth

**Country:** United Kingdom

**Location 227:**

**City:** Southampton

**Country:** United Kingdom

**Location 228:**

**City:** Sutton

**Country:** United Kingdom

**Location 229:**

**City:** Welwyn Garden City

**Country:** United Kingdom

**Location 230:**

**City:** Wirral

**Country:** United Kingdom

#### Overall Officials

**Official 1:**

**Affiliation:** Incyte Corporation

**Name:** Fitzroy Dawkins, M.D.

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Hurwitz H, Van Cutsem E, Bendell J, Hidalgo M, Li CP, Salvo MG, Macarulla T, Sahai V, Sama A, Greeno E, Yu KH, Verslype C, Dawkins F, Walker C, Clark J, O'Reilly EM. Ruxolitinib + capecitabine in advanced/metastatic pancreatic cancer after disease progression/intolerance to first-line therapy: JANUS 1 and 2 randomized phase III studies. Invest New Drugs. 2018 Aug;36(4):683-695. doi: 10.1007/s10637-018-0580-2. Epub 2018 Mar 6.

**PMID:** 29508247

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Pancreatic Cancer

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M377

- Name: Capecitabine

- Relevance: HIGH

- As Found: Function

- ID: M22554

- Name: Pancrelipase

- Relevance: LOW

- As Found: Unknown

- ID: M13114

- Name: Pancreatin

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069287

- Term: Capecitabine

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).

#### Event Groups

**Group ID:** EG000

**Title:** Ruxolitinib Plus Capecitabine

**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).

**ID:** EG000

**Other Num Affected:** 147

**Other Num at Risk:** 153

**Serious Number Affected:** 94

**Serious Number At Risk:** 153

**Title:** Ruxolitinib Plus Capecitabine

**Group ID:** EG001

**Title:** Placebo Plus Capecitabine

**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).

**ID:** EG001

**Other Num Affected:** 145

**Other Num at Risk:** 154

**Serious Number Affected:** 83

**Serious Number At Risk:** 154

**Title:** Placebo Plus Capecitabine

**Frequency Threshold:** 5

#### Other Events

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Anemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Palmar-plantar erythrodysaesthesia syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.0)

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.0)

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.0)

**Term:** Flatulence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Hiccups

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Muscular weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Dysgeusia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Dry mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 154

**Term:** Disseminated intravascular coagulation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Leukocytosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Pancytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Cardiac arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Cardiac failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Coronary artery disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Sinus tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Conjunctival haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 19

**Num At Risk:** 154

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 154

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 154

**Term:** Duodenal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 154

**Term:** Duodenal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Enteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Enterocolitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Haematemesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Impaired gastric emptying

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Intestinal infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Intestinal perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Melaena

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 154

**Term:** Obstruction gastric

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Oesophageal varices haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Pancreatic pseudocyst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Peritoneal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Small intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Upper gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 154

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 154

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 154

**Term:** Device leakage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Device malfunction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** General physical health deterioration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 154

**Term:** Hypothermia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Multi-organ failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Systemic inflammatory response syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Bile duct obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 154

**Term:** Bile duct stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Biliary dilatation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Biloma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Cholangitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Cholecystitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Hepatic failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Hepatic function abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Hyperbilirubinaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Jaundice

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 154

**Term:** Jaundice cholestatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Portal vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Biliary sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Biliary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Candida infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Cholangitis suppurative

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Device related infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Escherichia infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Klebsiella infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Klebsiella sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Liver abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Lower respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Peritonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Peritonitis bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 154

**Term:** Pneumonia klebsiella

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Postoperative abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 154

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Skin candida

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Accidental overdose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Spinal compression fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Hepatic enzyme increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Liver function test abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Transaminases increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** White blood cell count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 154

**Term:** Failure to thrive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Hyperkalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Hypoglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Hypovolaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Malnutrition

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 154

**Term:** Flank pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Mobility decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Muscular weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 154

**Term:** Musculoskeletal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Cancer pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Metastases to peritoneum

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Small intestine carcinoma metastatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Tumour associated fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Tumour pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Complex regional pain syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Ischaemic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Lethargy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Parkinson's disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Unresponsive to stimuli

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Confusional state

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Delirium

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Mental status changes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Renal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Renal failure acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Ureteric obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Atelectasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Chronic obstructive pulmonary disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 154

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Hypoxia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 154

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Pulmonary oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Respiratory arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Skin ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 153

**Group ID:** EG001

**Num At Risk:** 154

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 154

**Term:** Phlebitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (17.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 153

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 154

**Time Frame:** From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 161

**Group ID:** BG001

**Value:** 160

**Group ID:** BG002

**Value:** 321

**Units:** Participants

### Group

**ID:** BG000

**Title:** Ruxolitinib Plus Capecitabine

**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).

### Group

**ID:** BG001

**Title:** Placebo Plus Capecitabine

**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.35

**Value:** 67.3

#### Measurement

**Group ID:** BG001

**Spread:** 9.55

**Value:** 65.6

#### Measurement

**Group ID:** BG002

**Spread:** 9.48

**Value:** 66.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 65

#### Measurement

**Group ID:** BG001

**Value:** 68

#### Measurement

**Group ID:** BG002

**Value:** 133

**Class Title:** ≤ 65 years

#### Measurement

**Group ID:** BG000

**Value:** 96

#### Measurement

**Group ID:** BG001

**Value:** 92

#### Measurement

**Group ID:** BG002

**Value:** 188

**Class Title:** > 65 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 66

#### Measurement

**Group ID:** BG001

**Value:** 64

#### Measurement

**Group ID:** BG002

**Value:** 130

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 95

#### Measurement

**Group ID:** BG001

**Value:** 96

#### Measurement

**Group ID:** BG002

**Value:** 191

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation at the recommendation of the Data Monitoring Committee.
### Point of Contact
**Organization:** Incyte Corporation
**Phone:** 855 463-3463
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.747
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.256
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.969
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.827
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.348
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 1.056
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 124
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 36
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 41.0
- **Spread:** 
- **Upper Limit:** 46.0
- **Value:** 43.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 42.0
- **Spread:** 
- **Upper Limit:** 48.0
- **Value:** 44.0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12.7
- **Spread:** 
- **Upper Limit:** 25.9
- **Value:** 18.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 13.6
- **Spread:** 
- **Upper Limit:** 26.8
- **Value:** 19.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.5
- **Spread:** 
- **Upper Limit:** 12.2
- **Value:** 6.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.3
- **Spread:** 
- **Upper Limit:** 11.3
- **Value:** 5.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.5
- **Spread:** 
- **Upper Limit:** 7.5
- **Value:** 2.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.0
- **Spread:** 
- **Upper Limit:** 8.5
- **Value:** 3.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.5
- **Spread:** 
- **Upper Limit:** 7.5
- **Value:** 2.5
- **Comment:** PFS was not evaluable in the placebo group due to the insufficient number of participants with events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.9
**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:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.9
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** The median duration of response was not evaluable in the treatment group due to the insufficient number of participants with events.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** The median duration of response was not evaluable in the treatment group due to the insufficient number of participants with events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 152
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 152
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 73
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 83
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 112
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 68
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 131
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 122
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 60
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 46
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
**Reporting Status:** POSTED
**Time Frame:** Randomization until death due to any cause; up to the data cutoff 11FEB2016.
**Title:** Overall Survival (OS)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
#### Outcome Measure 2
**Description:** Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
**Reporting Status:** POSTED
**Time Frame:** Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
**Title:** Progression-free Survival (PFS)
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
#### Outcome Measure 3
**Description:** PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
**Reporting Status:** POSTED
**Time Frame:** Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
**Title:** Percentage of Participants Achieving Progression Free Survival (PFS)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
#### Outcome Measure 4
**Description:** Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
**Reporting Status:** POSTED
**Time Frame:** Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
**Title:** Objective Response Rate (ORR)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
#### Outcome Measure 5
**Description:** Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
**Reporting Status:** POSTED
**Time Frame:** Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
**Title:** Duration of Response
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
#### Outcome Measure 6
**Description:** A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
**Reporting Status:** POSTED
**Time Frame:** Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
**Title:** Participants With Treatment-Emergent Adverse Events (TEAEs)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
### Participant Flow Module
#### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** FG000
**Title:** Ruxolitinib Plus Capecitabine
#### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** FG001
**Title:** Placebo Plus Capecitabine
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 13
###### Reason
**Group ID:** FG001
**Number of Subjects:** 8
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 16
##### Withdraw
**Type:** Subject decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 9
##### Withdraw
**Type:** Disease progression
###### Reason
**Group ID:** FG000
**Number of Subjects:** 104
###### Reason
**Group ID:** FG001
**Number of Subjects:** 108
##### Withdraw
**Type:** Noncompliance with study treatment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Study terminated by the sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Other unspecified
###### Reason
**Group ID:** FG000
**Number of Subjects:** 11
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 161
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 160
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 4
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 156
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 156
**Pre-Assignment Details:** Treatment was started as soon as possible after randomization (within 3 days) and consisted of continuous 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered for the entire cycle.
**Recruitment Details:** Participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were randomized in the study.
**Has Results:** True