## Protocol Section
### Identification Module
**NCT ID:** NCT00251979

**Brief Title:** A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer

**Official Title:** A Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.

#### Organization Study ID Info
**ID:** D961DC00001
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2007-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-06-17

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-05-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2011-06-17

**Type:** ESTIMATED

**Results First Submit Date:** 2008-12-12

**Results First Submit QC Date:** 2011-05-18

#### Start Date
**Date:** 2005-10

**Status Verified Date:** 2011-05

#### Study First Post Date
**Date:** 2005-11-11
**Type:** ESTIMATED
**Study First Submit Date:** 2005-11-09
**Study First Submit QC Date:** 2005-11-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

### Description Module

**Brief Summary:** This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

### Conditions Module

**Conditions:**

- Gastrointestinal Hemorrhage

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1312

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Esomeprazole

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo

**Time Frame:** Within 72 hours

#### Secondary Outcomes

**Measure:** Clinically Significant Rebleeding Within 7 Days

**Time Frame:** Within 7 days

**Measure:** Clinically Significant Rebleeding Within 30 Days

**Time Frame:** Within 30 days

**Measure:** Death Within 72 Hours

**Time Frame:** Within 72 hours

**Measure:** Death Within 30 Days

**Time Frame:** Within 30 days

**Measure:** Death Related to Rebleeding Within 30 Days as Judged by the EpC

**Time Frame:** Within 30 days

**Measure:** Requirement for Surgery Within 72 Hours

**Time Frame:** Within 72 hours

**Measure:** Requirement for Surgery Within 30 Days

**Time Frame:** Within 30 days

**Measure:** Requirement for Endoscopic Re-treatment Within 72 Hours

**Time Frame:** Within 72 hours

**Measure:** Requirement for Endoscopic Re-treatment Within 30 Days

**Time Frame:** Within 30 days

**Measure:** Number of Blood Units Transfused Within 72 Hours

**Time Frame:** Within 72 hours

**Measure:** Number of Blood Units Transfused Within 30 Days

**Time Frame:** within 30 days

**Measure:** Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period

**Time Frame:** Within 30 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Signs of a bleeding in the stomach
* One endoscopically confirmed bleeding ulcer in the stomach or duodenum

Exclusion Criteria:

* Malignancy or other advanced disease.
* Major cardiovascular event.
* Severe hepatic disease

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Braunau/Inn

**Country:** Austria

**Facility:** Research Site

**Location 2:**

**City:** Feldbach

**Country:** Austria

**Facility:** Research Site

**Location 3:**

**City:** Graz

**Country:** Austria

**Facility:** Research Site

**Location 4:**

**City:** Krems

**Country:** Austria

**Facility:** Research Site

**Location 5:**

**City:** Wels

**Country:** Austria

**Facility:** Research Site

**Location 6:**

**City:** Wien

**Country:** Austria

**Facility:** Research Site

**Location 7:**

**City:** Aalborg

**Country:** Denmark

**Facility:** Research Site

**Location 8:**

**City:** Amager

**Country:** Denmark

**Facility:** Research Site

**Location 9:**

**City:** Glostrup

**Country:** Denmark

**Facility:** Research Site

**Location 10:**

**City:** Holstebro

**Country:** Denmark

**Facility:** Research Site

**Location 11:**

**City:** Kobenhavn

**Country:** Denmark

**Facility:** Research Site

**Location 12:**

**City:** Odense

**Country:** Denmark

**Facility:** Research Site

**Location 13:**

**City:** Randers

**Country:** Denmark

**Facility:** Research Site

**Location 14:**

**City:** Slagelse

**Country:** Denmark

**Facility:** Research Site

**Location 15:**

**City:** Helsinki

**Country:** Finland

**Facility:** Research Site

**Location 16:**

**City:** Kuopio

**Country:** Finland

**Facility:** Research Site

**Location 17:**

**City:** Amiens

**Country:** France

**Facility:** Research Site

**Location 18:**

**City:** Bordeaux

**Country:** France

**Facility:** Research Site

**Location 19:**

**City:** Clermont-Ferrand CEDEX 1

**Country:** France

**Facility:** Research Site

**Location 20:**

**City:** Lille

**Country:** France

**Facility:** Research Site

**Location 21:**

**City:** Nice Cedex 3

**Country:** France

**Facility:** Research Site

**Location 22:**

**City:** Paris Cedex 12

**Country:** France

**Facility:** Research Site

**Location 23:**

**City:** Paris Cedex 13

**Country:** France

**Facility:** Research Site

**Location 24:**

**City:** Rouen

**Country:** France

**Facility:** Research Site

**Location 25:**

**City:** Berlin

**Country:** Germany

**Facility:** Research Site

**Location 26:**

**City:** Bochum

**Country:** Germany

**Facility:** Research Site

**Location 27:**

**City:** Celle

**Country:** Germany

**Facility:** Research Site

**Location 28:**

**City:** Dresden

**Country:** Germany

**Facility:** Research Site

**Location 29:**

**City:** Karlsruhe

**Country:** Germany

**Facility:** Research Site

**Location 30:**

**City:** Leipzig

**Country:** Germany

**Facility:** Research Site

**Location 31:**

**City:** Ludwigshafen

**Country:** Germany

**Facility:** Research Site

**Location 32:**

**City:** Magdeburg

**Country:** Germany

**Facility:** Research Site

**Location 33:**

**City:** Weimar

**Country:** Germany

**Facility:** Research Site

**Location 34:**

**City:** Athens

**Country:** Greece

**Facility:** Research Site

**Location 35:**

**City:** Thessaloniki

**Country:** Greece

**Facility:** Research Site

**Location 36:**

**City:** Hong Kong

**Country:** Hong Kong

**Facility:** Research Site

**Location 37:**

**City:** Arnhem

**Country:** Netherlands

**Facility:** Research Site

**Location 38:**

**City:** Dordrecht

**Country:** Netherlands

**Facility:** Research Site

**Location 39:**

**City:** Hengelo

**Country:** Netherlands

**Facility:** Research Site

**Location 40:**

**City:** Nieuwegein

**Country:** Netherlands

**Facility:** Research Site

**Location 41:**

**City:** Rotterdam

**Country:** Netherlands

**Facility:** Research Site

**Location 42:**

**City:** Zwolle

**Country:** Netherlands

**Facility:** Research Site

**Location 43:**

**City:** Alesund

**Country:** Norway

**Facility:** Research Site

**Location 44:**

**City:** Drammen

**Country:** Norway

**Facility:** Research Site

**Location 45:**

**City:** Kristiansand

**Country:** Norway

**Facility:** Research Site

**Location 46:**

**City:** Lorenskog

**Country:** Norway

**Facility:** Research Site

**Location 47:**

**City:** Oslo

**Country:** Norway

**Facility:** Research Site

**Location 48:**

**City:** Tonsberg

**Country:** Norway

**Facility:** Research Site

**Location 49:**

**City:** Bucharest

**Country:** Romania

**Facility:** Research Site

**Location 50:**

**City:** Craiova

**Country:** Romania

**Facility:** Research Site

**Location 51:**

**City:** Iasi

**Country:** Romania

**Facility:** Research Site

**Location 52:**

**City:** Tg. Mures

**Country:** Romania

**Facility:** Research Site

**Location 53:**

**City:** Timisoara

**Country:** Romania

**Facility:** Research Site

**Location 54:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Research Site

**Location 55:**

**City:** Saint Petersburg

**Country:** Russian Federation

**Facility:** Research Site

**Location 56:**

**City:** Bloemfontein

**Country:** South Africa

**Facility:** Research Site

**Location 57:**

**City:** Cape Town

**Country:** South Africa

**Facility:** Research Site

**Location 58:**

**City:** Pietermaritzburg

**Country:** South Africa

**Facility:** Research Site

**Location 59:**

**City:** Barcelona

**Country:** Spain

**Facility:** Research Site

**Location 60:**

**City:** Madrid

**Country:** Spain

**Facility:** Research Site

**Location 61:**

**City:** Sabadell

**Country:** Spain

**Facility:** Research Site

**Location 62:**

**City:** Santiago

**Country:** Spain

**Facility:** Research Site

**Location 63:**

**City:** Goteborg

**Country:** Sweden

**Facility:** Research Site

**Location 64:**

**City:** Karlstad

**Country:** Sweden

**Facility:** Research Site

**Location 65:**

**City:** Kristianstad

**Country:** Sweden

**Facility:** Research Site

**Location 66:**

**City:** Linköping

**Country:** Sweden

**Facility:** Research Site

**Location 67:**

**City:** Norrkoping

**Country:** Sweden

**Facility:** Research Site

**Location 68:**

**City:** Ostersund

**Country:** Sweden

**Facility:** Research Site

**Location 69:**

**City:** Skövde

**Country:** Sweden

**Facility:** Research Site

**Location 70:**

**City:** Stockholm

**Country:** Sweden

**Facility:** Research Site

**Location 71:**

**City:** Sundsvall

**Country:** Sweden

**Facility:** Research Site

**Location 72:**

**City:** Trollhättan

**Country:** Sweden

**Facility:** Research Site

**Location 73:**

**City:** Ankara

**Country:** Turkey

**Facility:** Research Site

**Location 74:**

**City:** Bursa

**Country:** Turkey

**Facility:** Research Site

**Location 75:**

**City:** Izmir

**Country:** Turkey

**Facility:** Research Site

**Location 76:**

**City:** Izmit

**Country:** Turkey

**Facility:** Research Site

**Location 77:**

**City:** Birmingham

**Country:** United Kingdom

**Facility:** Research Site

**Location 78:**

**City:** Derby

**Country:** United Kingdom

**Facility:** Research Site

**Location 79:**

**City:** Leeds

**Country:** United Kingdom

**Facility:** Research Site

#### Overall Officials

**Official 1:**

**Affiliation:** AstraZeneca

**Name:** AstraZeneca Nexium Medical Sciences Director

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Chinese University of Hong Kong

**Name:** Joseph Sung, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Lau J, Lind T, Persson T, Eklund S. Effect of baseline characteristics on response to proton pump inhibitors in patients with peptic ulcer bleeding. J Dig Dis. 2017 Feb;18(2):99-106. doi: 10.1111/1751-2980.12447.

**PMID:** 28070941

**Citation:** Kuipers EJ, Sung JJ, Barkun A, Mossner J, Jensen D, Stuart R, Lau JY, Ahlbom H, Lind T, Kilhamn J. Safety and tolerability of high-dose intravenous esomeprazole for prevention of peptic ulcer rebleeding. Adv Ther. 2011 Feb;28(2):150-9. doi: 10.1007/s12325-010-0095-5. Epub 2010 Dec 15.

**PMID:** 21181319

**Citation:** Barkun AN, Adam V, Sung JJ, Kuipers EJ, Mossner J, Jensen D, Stuart R, Lau JY, Naucler E, Kilhamn J, Granstedt H, Liljas B, Lind T. Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding. Pharmacoeconomics. 2010;28(3):217-30. doi: 10.2165/11531480-000000000-00000.

**PMID:** 20151726

**Citation:** Sung JJ, Barkun A, Kuipers EJ, Mossner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. doi: 10.7326/0003-4819-150-7-200904070-00105. Epub 2009 Feb 16.

**PMID:** 19221370

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000004378

- Term: Duodenal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000013272

- Term: Stomach Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M9557

- Name: Gastrointestinal Hemorrhage

- Relevance: HIGH

- As Found: Gastrointestinal Hemorrhage

- ID: M13348

- Name: Peptic Ulcer

- Relevance: HIGH

- As Found: Peptic Ulcer

- ID: M13349

- Name: Peptic Ulcer Hemorrhage

- Relevance: HIGH

- As Found: Bleeding Peptic Ulcers

- ID: M7552

- Name: Duodenal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- 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: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010437

- Term: Peptic Ulcer

- ID: D000006471

- Term: Gastrointestinal Hemorrhage

- ID: D000010438

- Term: Peptic Ulcer Hemorrhage

- ID: D000006470

- Term: Hemorrhage

### Intervention Browse Module - Ancestors

- ID: D000000897

- Term: Anti-Ulcer Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000054328

- Term: Proton Pump Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Coag

- Name: Coagulants

### Intervention Browse Module - Browse Leaves

- ID: M30204

- Name: Esomeprazole

- Relevance: HIGH

- As Found: Risk of

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

- ID: M4188

- Name: Antacids

- Relevance: LOW

- As Found: Unknown

- ID: M4219

- Name: Anti-Ulcer Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27630

- Name: Proton Pump Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000064098

- Term: Esomeprazole

### Misc Info Module

#### Removed Countries

- Country: Argentina

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Esomeprazole

**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

**ID:** EG000

**Other Num Affected:** 87

**Other Num at Risk:** 375

**Serious Number Affected:** 61

**Title:** Esomeprazole

**Group ID:** EG001

**Title:** Placebo

**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

**ID:** EG001

**Other Num Affected:** 129

**Other Num at Risk:** 389

**Serious Number Affected:** 68

**Title:** Placebo

**Frequency Threshold:** 2

#### Other Events

**Term:** ABDOMINAL PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** ABDOMINAL PAIN UPPER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** ANAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

**Term:** CONSTIPATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** CYSTITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 10.0

**Term:** DIARRHOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** DIZZINESS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** DYSPNOEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

**Term:** HEADACHE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** HYPERTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** HYPOKALAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** INSOMNIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** NAUSEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** PHLEBITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** PYREXIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

**Term:** URINARY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 10.0

#### Serious Events

**Term:** ACUTE MYOCARDIAL INFARCTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 389

**Term:** ACUTE PSYCHOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** ADENOCARCINOMA PANCREAS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** ANGINA PECTORIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** ANGINA UNSTABLE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** ATRIAL FIBRILLATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 389

**Term:** BENIGN GASTRIC NEOPLASM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** BRADYCARDIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** CARDIAC FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** CHOLECYSTITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** CHRONIC OBSTRUCTIVE PULMONARY DISEASE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** COLONIC POLYP

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** CONSTIPATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** DIABETES MELLITUS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** DIABETES MELLITUS INADEQUATE CONTROL

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** DISCOMFORT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** DISLOCATION OF JOINT PROSTHESIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** DIZZINESS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** DUODENAL PERFORATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** DUODENAL ULCER HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 16

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 21

**Num At Risk:** 389

**Term:** DUODENAL ULCER PERFORATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** ERYSIPELAS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** FATIGUE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** GASTRIC CANCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** GASTRIC ULCER HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 13

**Num At Risk:** 389

**Term:** GASTRIC ULCER PERFORATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** GASTROENTERITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** GASTROINTESTINAL HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** GASTROINTESTINAL STROMAL TUMOUR

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** GOUT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** GOUTY ARTHRITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 389

**Term:** HAEMOGLOBIN DECREASED

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** HIP FRACTURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** HYPONATRAEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** LOWER RESPIRATORY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** LUNG DISORDER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** LUNG INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** LUNG INFILTRATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** MELAENA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** MYOCARDIAL INFARCTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 389

**Term:** OSTEOLYSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** PANCREATITIS ACUTE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** PEPTIC ULCER PERFORATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** PERIPHERAL NERVE LESION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** PERITONITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** PHLEBITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** PLEURAL EFFUSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** PNEUMONIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** PNEUMOTHORAX TRAUMATIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** PRESYNCOPE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** PULMONARY EMBOLISM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 389

**Term:** PULMONARY OEDEMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** PYREXIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** RECTAL CANCER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** RECTAL HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** RENAL FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** RESPIRATORY FAILURE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** RESPIRATORY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** SHOCK

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** SUBDURAL HAEMORRHAGE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** SYNCOPE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** TESTICULAR CANCER METASTATIC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** THROMBOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Num At Risk:** 389

**Term:** TRANSIENT ISCHAEMIC ATTACK

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** URINARY TRACT INFECTION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 375

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 389

**Term:** URTICARIA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Term:** UVEITIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

**Term:** VENOUS THROMBOSIS LIMB

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 375

**Group ID:** EG001

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 375

**Group ID:** BG001

**Value:** 389

**Group ID:** BG002

**Value:** 764

**Units:** Participants

### Group

**ID:** BG000

**Title:** Esomeprazole

**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 182

#### Measurement

**Group ID:** BG001

**Value:** 210

#### Measurement

**Group ID:** BG002

**Value:** 392

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

#### Measurement

**Group ID:** BG000

**Value:** 193

#### Measurement

**Group ID:** BG001

**Value:** 179

#### Measurement

**Group ID:** BG002

**Value:** 372

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 121

#### Measurement

**Group ID:** BG001

**Value:** 121

#### Measurement

**Group ID:** BG002

**Value:** 242

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 254

#### Measurement

**Group ID:** BG001

**Value:** 268

#### Measurement

**Group ID:** BG002

**Value:** 522

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrialTransparency@astrazeneca.com
**Organization:** AstraZeneca
**Title:** Gerard Lynch
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 492
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 738
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 589
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 935
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 284
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 500
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 72 hours
**Title:** Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 7 days
**Title:** Clinically Significant Rebleeding Within 7 Days
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 30 days
**Title:** Clinically Significant Rebleeding Within 30 Days
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 72 hours
**Title:** Death Within 72 Hours
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 30 days
**Title:** Death Within 30 Days
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 30 days
**Title:** Death Related to Rebleeding Within 30 Days as Judged by the EpC
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 72 hours
**Title:** Requirement for Surgery Within 72 Hours
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 8
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 30 days
**Title:** Requirement for Surgery Within 30 Days
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 9
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 72 hours
**Title:** Requirement for Endoscopic Re-treatment Within 72 Hours
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 10
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 30 days
**Title:** Requirement for Endoscopic Re-treatment Within 30 Days
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 11
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 72 hours
**Title:** Number of Blood Units Transfused Within 72 Hours
**Type:** SECONDARY
**Unit of Measure:** blood units
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 12
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** within 30 days
**Title:** Number of Blood Units Transfused Within 30 Days
**Type:** SECONDARY
**Unit of Measure:** blood units
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 13
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Within 30 days
**Title:** Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG000
**Title:** Esomeprazole
##### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** FG000
**Title:** Esomeprazole
#### Group
**Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 11
###### Reason
**Group ID:** FG001
**Number of Subjects:** 17
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 13
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 375
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 389
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 337
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 349
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 38
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 40
**Has Results:** True