Study of Esomeprazole 20 mg or 40 mg vs Placebo Effective... | NCT00441727

ID	Type	Description	Link
EudraCT No. 2006-005073-22

Label	Type	Description	Intervention Names
Esomeprazole 40 mg	Experimental	Esomeprazole 40 mg	Drug: Esomeprazole 40 mg
Esomeprazole 20 mg	Experimental	Esomeprazole 20 mg	Drug: Esomeprazole 20 mg
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Esomeprazole 40 mg	Drug	Esomeprazole 40 mg once daily	Esomeprazole 40 mg

Measure	Description	Time Frame
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).	The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.	During 26 weeks

Measure	Description	Time Frame
Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.	The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.	During 26 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the following (a-e):
Aged ≥65 years.
Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).
Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization).
Aged ≥60 years and with stable coronary artery disease.
Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.

Exclusion Criteria:

Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).
Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
History of peptic ulcer complications such as clinically significant bleeding and/or perforation.

Name	Affiliation	Role
Tore Lind, MD, PhD	AstraZeneca	Study Director
James Scheiman, MD	University of Michigan	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama		United States
Research Site

PubMed Identifier	Type	Citation	Retractions
23188121	Derived	Scheiman JM, Herlitz J, Veldhuyzen van Zanten SJ, Lanas A, Agewall S, Naucler EC, Svedberg LE, Nagy P. Esomeprazole for prevention and resolution of upper gastrointestinal symptoms in patients treated with low-dose acetylsalicylic acid for cardiovascular protection: the OBERON trial. J Cardiovasc Pharmacol. 2013 Mar;61(3):250-7. doi: 10.1097/FJC.0b013e31827cb626.
21415072

ID	Title	Description
FG000	Esomeprazole 40	Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
FG001	Esomeproazole 20	Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).

The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Posted

Number

percentage of participants

During 26 weeks

ID	Title	Description
OG000	Esomeprazole 40	Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
OG001	Esomeproazole 20	Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
OG002	Placebo	Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)

Units	Counts
Participants	OG000817 OG001804 OG002805

Title

Denominators

Categories

Title	Measurements
	OG0001.35 OG0011 OG0026.58

Secondary

Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.

The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Posted

Number

percentage of participants

During 26 weeks

ID	Title	Description
OG000	Esomeprazole 40	Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
OG001	Esomeproazole 20	Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
OG002	Placebo	Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)

Units	Counts
Participants

Secondary

Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.

The occurrence of duodenal ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Posted

Number

percentage of participants

During 26 weeks

ID	Title	Description
OG000	Esomeprazole 40	Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
OG001	Esomeproazole 20	Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
OG002	Placebo	Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)

Units	Counts
Participants

Secondary

Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.

RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence.

Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.

Posted

Number

participants

RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.

ID	Title	Description
OG000	Esomeprazole 40 mg	Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
OG001	Esomeprazole 20 mg	Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
OG002	Placbo	Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)

Secondary

Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.

RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'. Best score possible 0, worst score possible - daily occurrence.

Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.

Posted

Number

participants

RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.

ID	Title	Description
OG000	Esomeprazole 40 mg	Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
OG001	Esomeproazole 20 mg	Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (acetylsalicyclic acid) (75-325 mg)
OG002	Placebo

Secondary

Number of Participants With Gastric and/or Duodenal Erosions.

Patients randomized who had endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Posted

Number

participants

The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

ID	Title	Description
OG000	Esomeprazole 40	Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
OG001	Esomeproazole 20	Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
OG002	Placebo	Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute Coronary Syndrome	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Angina Pectoris	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Angina Unstable	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0021 affected801 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0012 affected799 at risk EG0021 affected801 at risk
Cardiac Failure	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0021 affected801 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected814 at risk EG0011 affected799 at risk EG0021 affected801 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Acromegaly	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Colitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Duodenal Perforation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Gastritis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Irritable Bowel Syndrome	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Subileus	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Chest Pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Death	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Sudden Death	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Hepatitis Toxic	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Diverticulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Erysipelas	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Lobar Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Meningitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Pyelonephritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Sepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Dislocation Of Joint Prosthesis	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Gout	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0021 affected801 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Adenocarcinoma Pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Bile Duct Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Gastrointestinal Tract Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Lentigo Maligna Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Oesophageal Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0021 affected801 at risk
Oesophageal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Signet-Ring Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Thyroid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Carotid Arteriosclerosis	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Cerebral Circulatory Failure	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0012 affected799 at risk EG0020 affected801 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Syncope	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0012 affected799 at risk EG0020 affected801 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Benign Prostatic Hyperplasia	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Pulmonary Sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0011 affected799 at risk EG0020 affected801 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Thromboangiitis Obliterans	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected814 at risk EG0010 affected799 at risk EG0021 affected801 at risk
Varicose Vein	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected814 at risk EG0010 affected799 at risk EG0020 affected801 at risk

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D013272	Stomach Diseases

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Esomeprazole 40	Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
BG001	Esomeproazole 20	Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
BG002	Placebo	Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Other Events (Affected)
EG000	Esomeprazole 40	Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)	46	32
EG001	Esomeproazole 20	Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)	40	42
EG002	Placebo	Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)	35	31

ID	Term
D013276	Stomach Ulcer
D004381	Duodenal Ulcer
D010437	Peptic Ulcer