A Randomized Trial of Medical and Surgical Treatments for... | NCT01265550

NCT01265550

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Brief Summary

Background: Gastroesophageal reflux disease (GERD), which affects at least 20% of adult Americans, may be especially common and severe in Veteran patients. Proton pump inhibitors (PPIs), which block gastric acid production, are the most effective medications for GERD, and the VA spends more than $177 million each year on outpatient PPI prescriptions. PPIs do not prevent the reflux of non-acidic material and do not completely eliminate esophageal acid exposure, however, and bothersome GERD symptoms persist in approximately 40% of patients treated with PPIs. Recent studies using the new technique of esophageal pH/ impedance monitoring, which detects the reflux of both acidic and non-acidic materials, have shown that PPI-resistant GERD symptoms correlate with episodes of reflux (acidic and/or non-acidic) in approximately one-half of patients. For those patients, an antireflux operation might relieve symptoms and obviate the expense of ineffective PPI therapy, but the efficacy of modern, laparoscopic fundoplication in this regard is not clear. For patients with PPI-resistant GERD symptoms, furthermore, the efficacy of medications that that can prevent gastroesophageal reflux (e.g. baclofen) or diminish pain of esophageal origin (e.g. neurotropic agents like desipramine) also is not clear. Study Hypothesis: Laparoscopic antireflux surgery (Nissen fundoplication) is superior to medical therapy (PPIs plus baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring.

Study Goals: The primary goal is to compare the efficacy of laparoscopic Nissen fundoplication and medical therapy (PPIs plus baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring, and to compare the efficacy of each therapy with placebo. Secondary goals are: 1) To determine the frequency with which non-GERD disorders underlie "PPI failure," 2) To determine the frequency of functional gastrointestinal symptoms, anxiety and depression in patients who have persistent heartburn while on PPIs, 3) To determine whether functional gastrointestinal symptoms, anxiety and depression is associated with the outcomes of medical and surgical therapies, and 4) To determine whether the outcome of Nissen fundoplication is associated with adherence to technical aspects of the operation.

Study Design: Up to 16 VA medical centers, there will be a 30-month recruitment period to enroll 108 patients with heartburn that is refractory to PPI therapy. Patients will have their baseline GERD symptoms scored using the GERD Health-Related Quality of Life (GERD-HRQL) index, and will have endoscopy, esophageal manometry and esophageal pH/impedance monitoring while on PPI therapy. Patients who have episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring will be randomized to one of three treatment groups: Surgical Treatment (laparoscopic Nissen fundoplication), Active Medical Treatment (omeprazole and baclofen initially; desipramine for baclofen failures) or Placebo Medical Treatment (omeprazole, placebo baclofen, placebo desipramine). All patients will have quarterly clinic visits for symptom scoring and laboratory testing. At one year, patients will have a final symptom scoring and repeat endoscopy, esophageal manometry and esophageal pH/impedance monitoring. Treatment success will be defined as 50% improvement in the GERD-HRQL score at 12 months. Patients also will complete the Hospital Anxiety and Depression Scale (HADS), Rome III Functional GI Disorders Questionnaire and the Short-Form Health Survey (SF-36) at baseline and one year. The results will be correlated with treatment outcomes.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medical Treatment Group	Other	Omeprazole or Omeprazole + baclofen or Omeprazole + desipramine	Drug: baclofen Drug: Desipramine
Surgical Treatment Group	Other	Laparoscopic nissen fundoplications	Device: Nissen fundoplication
Placebo Medical Treatment Group	Other	Omeprazole + placebo	Drug: baclofen Drug: Desipramine

Name	Type	Description	Arm Group Labels	Other Names
Nissen fundoplication	Device	laparoscopic antireflux surgery	Surgical Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months	Success; ≥50% improvement in the baseline GERD-HRQL score at 12 months. Failure; <50% improvement in the baseline GERD-HRQL score at 12 months or: For patients randomized to Surgical Treatment: a.<50% improvement in the baseline GERD-HRQL score and/or persistent heartburn of sufficient severity to warrant treatment with any antisecretory medication, antireflux medication or neurotropic medication at any quarterly clinic visit. For patients randomized to Active Medical or Placebo Medical Treatment: a.inability to tolerate both study medications or b.For patients treated with desipramine, i.<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with the second drug at any quarterly clinic visit. c.For patients in whom desipramine is contraindicated,i.<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with baclofen or its corresponding placebo at any quarterly clinic visit.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Enrolled Participants With Esophageal Ulceration.		Screening
Number of Enrolled Participants With Reflux Esophagus.		Screening
Number of Enrolled Participants With Eosinophilic Esophagitis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-70 years
History of heartburn (defined as a burning sensation in the retrosternal area of the chest) that is refractory to antisecretory medications
Initial GERD-HRQL:
- Total score must be at least 6 and at least one of the six heartburn questions must be scored at least 2
GERD-HRQL after two weeks of treatment with omeprazole:
- Total score must be >50% of the initial GERD-HRQL score and at least one of the six heartburn questions must be scored at least 2
Either or both of the following by baseline esophageal pH/multichannel intraluminal impedance (MII) monitoring in patients on omeprazole 20 mg two times a day (BID):
- Positive symptom association probability (SAP) (>95%) for acid reflux, non-acid reflux or all reflux.
- Abnormal acid reflux (esophageal pH<4 for at least 4.2% of the 24-hour monitoring period)

Exclusion Criteria:

Patients who do not have heartburn, defined as a burning sensation in the chest
Patients unwilling or unable to provide informed consent
Pregnancy or women unwilling to use effective contraception
Age <18 or >70 years
History of surgery on the stomach or esophagus
History of seizure disorder
History of heart block
Allergy to or previous inability to tolerate study medications (omeprazole, baclofen, desipramine)
Esophageal varices
Cirrhosis
Co-morbidity of sufficient severity to preclude elective surgery (e.g. pulmonary, cardiac, renal, liver disease)
History of disorders that can cause medically-refractory "GERD symptoms" (eosinophilic esophagitis, neoplasms of the upper gastrointestinal tract, gastroparesis, achalasia)
Myocardial infarction within the past 6 months
History of schizophrenia
Current use of clopidogrel
Patients who have a contraindication to omeprazole or baclofen or who require therapy with a medication that has a clinically important drug interaction with omeprazole or baclofen.
Patients who, in the judgment of the PI, are not suitable candidates for therapy with a study medication (omeprazole, baclofen, desipramine)
Initial GERD-HRQL score: Total score <6 and/or all heartburn scores <2
Inability to tolerate omeprazole during the 2-week treatment phase (before randomization)
GERD-HRQL after two weeks of treatment with omeprazole: Total score less than or equal to 50% of initial GERD-HRQL score and/or all heartburn scores <2
Laboratory abnormalities including:
- Platelet count <100,000
- international normalized ratio (INR) >1.5 (off anticoagulants)
- Serum creatinine >2.0 mg per deciliter
Endoscopic abnormalities including:
- Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis
- Active ulceration of the esophagus that is not due to reflux esophagitis
- Candida esophagitis
- Esophageal varices
- Active ulceration of the stomach and/or duodenum
- Neoplasm of the esophagus, stomach or duodenum
- Gastric outlet obstruction
- Eosinophilic esophagitis at least (15 eosinophils per high power field in any esophageal biopsy specimen)
Manometric abnormalities including:
- Achalasia
- Complete aperistalsis
Negative SAP ( 95%) for acid reflux, non-acid reflux and all reflux on baseline combined esophageal pH/MII monitoring and normal acid reflux (esophageal pH<4 for <4.2% of the 24-hour monitoring period)
Study surgeon identifies a contraindication to laparoscopic Nissen fundoplication
Morbid obesity (BMI at least 40)
Large paraesophageal hernia

Contacts/Locations Module

Name	Affiliation	Role
Stuart J Spechler, MD	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham VA Medical Center, Birmingham, AL		Birmingham	Alabama	35233	United States
Southern Arizona VA Health Care System, Tucson, AZ

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31618539	Derived	Spechler SJ, Hunter JG, Jones KM, Lee R, Smith BR, Mashimo H, Sanchez VM, Dunbar KB, Pham TH, Murthy UK, Kim T, Jackson CS, Wallen JM, von Rosenvinge EC, Pearl JP, Laine L, Kim AW, Kaz AM, Tatum RP, Gellad ZF, Lagoo-Deenadayalan S, Rubenstein JH, Ghaferi AA, Lo WK, Fernando RS, Chan BS, Paski SC, Provenzale D, Castell DO, Lieberman D, Souza RF, Chey WD, Warren SR, Davis-Karim A, Melton SD, Genta RM, Serpi T, Biswas K, Huang GD. Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn. N Engl J Med. 2019 Oct 17;381(16):1513-1523. doi: 10.1056/NEJMoa1811424.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Medical Treatment Group	baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Medical Treatment Group	baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
BG001	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery
BG002	Placebo Medical Treatment Group	baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
BG003	Not Randomized	Subset of all enrolled participants who did not end up being randomized to the study.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Missing data

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00025 ParticipantsBG00127 ParticipantsBG00226 ParticipantsBG003

Sex: Female, Male

Missing data.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00025 ParticipantsBG00127 ParticipantsBG002

Ethnicity (NIH/OMB)

Missing data.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00025 ParticipantsBG00127 ParticipantsBG002

Race (NIH/OMB)

Missing data

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00025 ParticipantsBG00127 ParticipantsBG002

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 Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months

Success; ≥50% improvement in the baseline GERD-HRQL score at 12 months.

Failure; <50% improvement in the baseline GERD-HRQL score at 12 months or:

For patients randomized to Surgical Treatment: a.<50% improvement in the baseline GERD-HRQL score and/or persistent heartburn of sufficient severity to warrant treatment with any antisecretory medication, antireflux medication or neurotropic medication at any quarterly clinic visit.
For patients randomized to Active Medical or Placebo Medical Treatment:

a.inability to tolerate both study medications or b.For patients treated with desipramine, i.<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with the second drug at any quarterly clinic visit. c.For patients in whom desipramine is contraindicated,i.<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with baclofen or its corresponding placebo at any quarterly clinic visit.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Units	Counts
Participants	OG00025 OG00127 OG00226

Title

Denominators

Categories

Title	Measurements
	OG0007 OG00118 OG0023

Secondary

Number of Enrolled Participants With Esophageal Ulceration.

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for esophageal ulceration.

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000216

Title	Denominators

Secondary

Number of Enrolled Participants With Reflux Esophagus.

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for reflux esophagus.

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000216

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Eosinophilic Esophagitis

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for eosinophilic esophagitis

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000215

Title	Denominators

Secondary

Number of Enrolled Participants With Active Ulceration of the Stomach and/or Duodenum.

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for active ulcerations of the stomach and/or duodenum

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000216

Secondary

Number of Enrolled Participants With Neoplasm of the Esophagus, Stomach or Duodenum

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for neoplasm of the esophagus, stomach or duodenum

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000216

Title

Secondary

Number of Enrolled Participants With Candida Esophagitis.

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for candida esophagitis

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000216

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Gastric Outlet Obstruction

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for gastric outlet obstruction

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000216

Title	Denominators

Secondary

Number of Enrolled Participants With Achalasia

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for achalasia

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000212

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Aperistalsis

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for aperistalsis

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000212

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Distal Esophageal Spasm

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for distal esophageal spasm

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000212

Title	Denominators

Secondary

Number of Enrolled Participants With Nutcracker Esophagus

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for nutcracker esophagus

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG00032

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Ineffective Esophageal Motility

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for ineffective esophageal motility

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG00033

Title	Denominators

Secondary

Number of Enrolled Participants With Rapid Contraction

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for rapid contraction

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG00093

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Hypertensive Peristalsis

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for hypertensive peristalsis

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG00093

Title	Denominators

Secondary

Number of Enrolled Participants With Jackhammer Esophagus

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for jackhammer esophagus

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG00093

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Weak Peristalsis I

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for weak peristalsis I

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG00093

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Weak Peristalsis II

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for weak peristalsis II

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG00093

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Anxiety and/or Depression

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for anxiety and/or depression

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000272

Title	Denominators

Secondary

Number of Enrolled Participants With Functional Heartburn

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional heartburn

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000274

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Functional Chest Pain of Presumed Esophageal Origin

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional chest pain of presumed esophageal origin

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000276

Secondary

Number of Enrolled Participants With Functional Dysphagia

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional dysphagia

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000277

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Globus

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for globus

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000278

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Belching Disorders

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for belching disorders

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000273

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Chronic Idiopathic Nausea

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for chronic idiopathic nausea

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000273

Title	Denominators

Secondary

Number of Enrolled Participants With Functional Vomiting

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional vomiting

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000276

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Cyclic Vomiting Syndrome

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for cyclic vomiting syndrome

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000276

Title	Denominators

Secondary

Number of Enrolled Participants With Irritable Bowel Syndrome

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for irritable bowel syndrome

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000277

Title	Denominators

Secondary

Number of Enrolled Participants With Functional Bloating

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional bloating

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000277

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Functional Diarrhea

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional diarrhea

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000271

Title	Denominators	Categories

Secondary

Number of Enrolled Participants With Unspecified Functional Bowel Disorder

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for unspecified functional bowel disorder

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000278

Title

Secondary

Number of Enrolled Participants With Functional Gallbladder Disorder

The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional gallbladder disorder

Posted

Count of Participants

Participants

Screening

ID	Title	Description
OG000	All Enrolled	All patients consented.

Units	Counts
Participants	OG000278

Title	Denominators

Secondary

Number of Successful Participants With Anxiety and/or Depression.

Association between anxiety and/or depression (GAD-7 and PHQ-9) and the outcome of medical and surgical treatments (success or failure) will be evaluated.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Functional Heartburn

Presence of functional heartburn as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Functional Chest Pain of Presumed Esophageal Origin

Presence of functional chest pain of presumed esophageal origin as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Functional Dysphagia

Presence of functional dysphagia as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Globus

Presence of globus as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Belching Disorders

Presence of belching disorders as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Chronic Idiopathic Nausea

Presence of chronic idiopathic nausea as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Functional Vomiting

Presence of functional vomiting as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Cyclic Vomiting Syndrome

Presence of cyclic vomiting syndrome as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Irritable Bowel Syndrome

Presence of irritable bowel syndrome as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Functional Bloating

Presence of functional bloating as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Functional Diarrhea

Presence of functional diarrhea as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Unspecified Functional Bowel Disorder

Presence of unspecified functional bowel disorder as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Participants With Functional Gallbladder Disorder

Presence of functional gallbladder disorder as assessed by the ROME III functional GI disorders questionnaire.

Number of treatment successes

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medical Treatment Group	Omeprazole + baclofen or Omeprazole + desipramine baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
OG001	Surgical Treatment Group	Laparoscopic nissen fundoplications Nissen fundoplication: laparoscopic antireflux surgery
OG002	Placebo Medical Treatment Group	Omeprazole + placebo baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Secondary

Number of Successful Surgery Participants With Dissection of Distal Esophagus to Obtain at Least 2.5cm of Tension-free, Intra-abdominal Esophagus Performed.

Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery

Units	Counts
Participants	OG00018

Secondary

Number of Successful Surgery Participants With Complete Mobilization of the Fundus, to Include All Short Gastric and Posterior Gastric Vessels to the Base of the Left Crus Performed.

Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery

Units	Counts
Participants	OG00018

Secondary

Number of Successful Surgery Participants With Closure of the Crura With Non-absorbable Suture to be Snug With a Dilator of at Least 56 French Diameter Performed.

Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery

Units	Counts
Participants	OG00018

Secondary

Number of Successful Surgery Participants With Passage of an Esophageal Dilator of at Least 56 French Diameter Performed.

Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery

Units	Counts
Participants	OG00018

Secondary

Number of Successful Surgery Participants With Fundoplication Between 1.5 and 2.5cm in Length Performed.

Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery

Units	Counts
Participants	OG00018

Secondary

Number of Successful Surgery Participants With Fundoplication Placed Above the Epiphrenic Fat Pad, Using 3 Sutures Performed.

Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery

Units	Counts
Participants	OG00018

Secondary

Number of Successful Surgery Participants With Fundoplication Secured to Esophagus With at Least Two Sutures Performed.

Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery

Units	Counts
Participants	OG00018

Secondary

Number of Successful Surgery Participants With Fundoplication Floppiness Demonstrated by Passing a Grasper Between Fundoplication and Dilator-filled Esophagus Performed.

Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery

Units	Counts
Participants	OG00018

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Medical Treatment Group	baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.	25	4	25	18	25
EG001	Surgical Treatment Group	Nissen fundoplication: laparoscopic antireflux surgery	27	4	27	17	27
EG002	Placebo Medical Treatment Group	baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals. The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved. Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.	26	3	26	18	26
EG003	All Enrolled	All patients consented.	288	15	366	79	366

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG0033 events1 affected366 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Accident	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Fracture of penis	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Migraine	Nervous system disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Homicidal ideation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Post-traumatic stress disorder	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Suicidal ideation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0022 events1 affected26 at risk EG003
Violence-related symptom	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Temporal arteritis	Vascular disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0004 events3 affected25 at risk EG0011 events1 affected27 at risk EG0021 events1 affected26 at risk EG0039 events9 affected366 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected25 at risk EG0011 events1 affected27 at risk EG0022 events2 affected26 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0022 events1 affected26 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0022 events2 affected26 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected27 at risk EG0020 events0 affected26 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0015 events4 affected27 at risk EG0021 events1 affected26 at risk EG003
Faeces hard	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Faeces soft	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Food poisoning	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Gingival swelling	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Odynophagia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Tooth loss	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected25 at risk EG0012 events2 affected27 at risk EG0020 events0 affected26 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected25 at risk EG0011 events1 affected27 at risk EG0023 events3 affected26 at risk EG003
Cyclic vomiting syndrome	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Regurgitation	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected27 at risk EG0021 events1 affected26 at risk EG003
Post procedural discomfort	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0021 events1 affected26 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Animal bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Joint injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0021 events1 affected26 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Influenza	Infections and infestations	Systematic Assessment	EG0001 events1 affected25 at risk EG0012 events2 affected27 at risk EG0021 events1 affected26 at risk EG003
Bronchitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Diverticulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0022 events2 affected26 at risk EG003
Pharyngitis streptococcal	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Tooth infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0022 events2 affected26 at risk EG003
Urethritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Clostridium difficile colitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0021 events1 affected26 at risk EG003
Subcutaneous abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Migraine	Nervous system disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Sciatica	Nervous system disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Amnesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Essential tremor	Nervous system disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Somnolence	Nervous system disorders	Systematic Assessment	EG0004 events4 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Laryngospasm	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Tonsillar disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0022 events1 affected26 at risk EG003
Chest discomfort	General disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Infusion site pain	General disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Cyst	General disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Feeling jittery	General disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Influenza like illness	General disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Mucosal pain	General disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Hyperparathyroidism	Endocrine disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Thyroid mass	Endocrine disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Seasonal allergy	Immune system disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Laboratory test	Investigations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Blood HIV RNA increased	Investigations	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Blood glucose increased	Investigations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Blood magnesium decreased	Investigations	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Hepatic enzyme increased	Investigations	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Intraocular pressure increased	Investigations	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Liver function test abnormal	Investigations	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Weight increased	Investigations	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Hot flush	Vascular disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Basophilia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Macrocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Palpitations	Cardiac disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Dacryoadenitis acquired	Eye disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Gout	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected27 at risk EG0020 events0 affected26 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Increased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Anxiety	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Depression	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Hallucination, visual	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Mood altered	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected27 at risk EG0021 events1 affected26 at risk EG003
Sleep disorder	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected27 at risk EG0020 events0 affected26 at risk EG003

ID	Term
D005764	Gastroesophageal Reflux

ID	Term
D018662	Fundoplication
D001418	Baclofen
D003891	Desipramine

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D003984	Dibenzazepines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ParticipantsBG004358

ParticipantsBG003279

ParticipantsBG004357

ParticipantsBG003279

ParticipantsBG004357

ParticipantsBG003279

ParticipantsBG004357

Title

Denominators

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases