Esomeprazole (NEXIUM) vs. Surgery | NCT00251927

ID	Type	Description	Link
SH-NEG-0003

Label	Type	Description	Intervention Names
1	Active Comparator	Surgery	Procedure: Laparoscopic fundoplication (surgery)
2	Experimental	Esomeprazole (NEXIUM) therapy	Drug: esomeprazole

Name	Type	Description	Arm Group Labels	Other Names
esomeprazole	Drug	40 mg oral tablet administered daily	2	Nexium®

Measure	Description	Time Frame
Number of Participants With Treatment Failure at 5 Years	Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.	During 5 years

Measure	Description	Time Frame
Los Angeles (LA) Grade 'Normal' at 5 Year Visit	Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference

Name	Affiliation	Role
AstraZeneca Nexium Medical Sciences Director, MD	AstraZeneca	Study Director
Lars Lundell, MD, PhD	Karolinska University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Linz			Austria
Research Site

PubMed Identifier	Type	Citation	Retractions
26226096	Derived	Hatlebakk JG, Zerbib F, Bruley des Varannes S, Attwood SE, Ell C, Fiocca R, Galmiche JP, Eklund S, Langstrom G, Lind T, Lundell LR; LOTUS Study Group. Gastroesophageal Acid Reflux Control 5 Years After Antireflux Surgery, Compared With Long-term Esomeprazole Therapy. Clin Gastroenterol Hepatol. 2016 May;14(5):678-85.e3. doi: 10.1016/j.cgh.2015.07.025. Epub 2015 Jul 27.
25858519

ID	Title	Description
FG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
FG001	Esomeprazole Medical Arm

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

Number of Participants With Treatment Failure at 5 Years

Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.

Posted

Number

participants

During 5 years

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants	OG000288 OG001266

Title

Denominators

Categories

Title	Measurements
	OG00033 OG00119

Secondary

Los Angeles (LA) Grade 'Normal' at 5 Year Visit

Endoscopic findings classified according to the Los Angeles classification:

Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference

Posted

Number

participants

At 5 year visit

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants

Secondary

Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn

Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn

Posted

Number

participants

At 5 year visit

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants	OG000

Secondary

Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit

The total score expressed as a mean of all the scores/number of lesions assessed; scored 2 when erosion/necrosis is found. The score could range from 0 to 2 (maximum severity). Only participants with biopsy at 5 years visit included

Posted

Mean

Standard Error

units on a scale

At 5 year visit

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants	OG000

Secondary

Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit

Intra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included

Posted

Mean

Standard Deviation

percentage of time recorded

At 5 year visit

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants	OG000

Secondary

Los Angeles (LA) Grade 'A' at 5 Year Visit

Endoscopic findings classified according to the Los Angeles classification:

Posted

Number

participants

At 5 year visit

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants

Secondary

Los Angeles (LA) Grade 'B' at 5 Year Visit

Endoscopic findings classified according to the Los Angeles classification:

Posted

Number

participants

At 5 year visit

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants

Secondary

Los Angeles (LA) Grade C at 5 Year Visit

Endoscopic findings classified according to the Los Angeles classification:

Posted

Number

participants

At 5 year visit

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants

Secondary

Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn

Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn

Posted

Number

participants

At 5 year visit

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants	OG000

Secondary

Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn

Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn

Posted

Number

participants

At 5 year visit

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants	OG000

Secondary

Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn

Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn

Posted

Number

participants

At 5 year visit

ID	Title	Description
OG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
OG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Microcytic Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0012 affected266 at risk EG0020 affected40 at risk
Angina Pectoris	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0013 affected266 at risk EG0020 affected40 at risk
Arrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Arteriosclerosis Coronary Artery	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0021 affected40 at risk
Cardiac Failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected248 at risk EG0013 affected266 at risk EG0020 affected40 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Palpitations	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Pericarditis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Conductive Deafness	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Cataract	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Corneal Oedema	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Glaucoma	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Keratitis	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Retinal Vein Occlusion	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Acute Abdomen	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Barrett's Oesophagus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Colitis Ulcerative	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Colonic Pseudo-Obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Diverticulitis Intestinal Haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Flatulence	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Gastric Perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Gastric Ulcer Perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Gastritis Haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Gastrointestinal Motility Disorder	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Ileus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Ileus Paralytic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Impaired Gastric Emptying	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Lumbar Hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Mallory-Weiss Syndrome	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Subileus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Chest Discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Dysplasia	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Multi-Organ Failure	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected248 at risk EG0015 affected266 at risk EG0020 affected40 at risk
Oedema Peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Bile Duct Stenosis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0012 affected266 at risk EG0021 affected40 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Abscess Jaw	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0010 affected266 at risk EG0021 affected40 at risk
Appendicitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Diverticulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0012 affected266 at risk EG0020 affected40 at risk
Erysipelas	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0013 affected266 at risk EG0020 affected40 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0012 affected266 at risk EG0020 affected40 at risk
Pneumonia Primary Atypical	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Tubo-Ovarian Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Complication Of Device Insertion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Gas Poisoning	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Incisional Hernia	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Meniscus Lesion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Operative Haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Patella Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Post Procedural Complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Procedural Complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Skull Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Traumatic Brain Injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Urinary Bladder Rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0012 affected266 at risk EG0020 affected40 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0012 affected266 at risk EG0020 affected40 at risk
Foot Deformity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0014 affected266 at risk EG0020 affected40 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected248 at risk EG0012 affected266 at risk EG0020 affected40 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Adenocarcinoma Pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Benign Neoplasm Of Thyroid Gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Benign Peritoneal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Carcinoid Tumour Pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Chronic Lymphocytic Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Malignant Neoplasm Of Spermatic Cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Multiple Myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0012 affected266 at risk EG0020 affected40 at risk
Seminoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Tongue Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Polyneuropathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Sciatica	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Anxiety Disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Suicide Attempt	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Calculus Ureteric	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0012 affected266 at risk EG0020 affected40 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Ovarian Torsion	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Uterine Polyp	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Vaginal Prolapse	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Suffocation Feeling	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Vocal Cord Cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Skin Fissures	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0012 affected266 at risk EG0020 affected40 at risk
Arterial Thrombosis Limb	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Arteriosclerosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Embolism	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Necrosis Ischaemic	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0011 affected266 at risk EG0020 affected40 at risk
Varicose Vein	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected266 at risk EG0020 affected40 at risk

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System 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 Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
BG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Esomeprazole Surgical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.	103	248	248
EG001	Esomeprazole Medical Arm	Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)	101	266	266
EG002	Non-Surgical Arm	This group of patients was randomized to receive surgery but were on operated on and were followed for safety purposes	3	40	40