Safety and Tolerability Study of Rifaximin in Participant... | NCT00686920

Description Module

Detailed Description

Eligible participants had a history of HE, a Conn score of 0 to 2 at enrollment, and either had successfully participated in a previous HE study with rifaximin (that is, RFHE3001 [NCT00298038]), or were new participants enrolled with ≥1 verifiable episode of HE (equivalent to a Conn score of ≥2) associated with cirrhosis or portal hypertension within 12 months of screening.

Successful participation in a previous rifaximin study was defined as having received ≥80% and ≤120% of the expected tablets, having been reasonably compliant with study procedures, and having not been discontinued from the previous study due to study drug-related Adverse Events. Participants who experienced HE or associated symptoms during or after the RFHE3001 study were considered eligible for entry into this open-label study if the participant and Investigator did not perceive study medication as a possible cause of the HE episode or associated symptoms. Participants who did not participate in a previous HE study with rifaximin were eligible if this open-label study was the only rifaximin HE study available at an individual site.

Label	Type	Description	Intervention Names
Rifaximin	Experimental	Participants from a previous rifaximin HE study and new participants were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.	Drug: Rifaximin

Name	Type	Description	Arm Group Labels	Other Names
Rifaximin	Drug	Oral	Rifaximin	Xifaxan®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event	A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.	Baseline up to Month 36

Secondary Outcomes

Measure	Description	Time Frame
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	Hematology and blood chemistry with potentially significant values included: Hemoglobin <9, >18, or ≥3 (grams/deciliter [g/dL]) decrease from previous visit or ≥4 g/dL decrease from baseline; Hematocrit <0.27%, >0.54%, or ≥0.10% decrease from previous visit or ≥0.15% decrease from baseline; Platelets <50 or >40010^9/(liter [L]); Prothrombin time 9 seconds above baseline or upper limit of normal range; International normalized ratio >1.7; White blood cells <2.0 or >12.010^9/L; Lymphocytes <13.5% or >70%; Glucose, random, serum <2.2 or >16.5 millimole (mmol)/L; Potassium ≤3.0 or ≥5.5 mmol/L; Direct bilirubin increases 3-fold from baseline or >85.5 micromole (umol)/L. Baseline value was defined as the last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Eligibility Module

Name	Affiliation	Role
Lindsey Mathew	Bausch Health Companies	Study Director

PubMed Identifier	Type	Citation	Retractions
37467180	Derived	Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
24365449	Derived	Mullen KD, Sanyal AJ, Bass NM, Poordad FF, Sheikh MY, Frederick RT, Bortey E, Forbes WP. Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1390-7.e2. doi: 10.1016/j.cgh.2013.12.021. Epub 2013 Dec 21.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	New Rifaximin	Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Secondary

Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants

Hematology and blood chemistry with potentially significant values included: Hemoglobin <9, >18, or ≥3 (grams/deciliter [g/dL]) decrease from previous visit or ≥4 g/dL decrease from baseline; Hematocrit <0.27%, >0.54%, or ≥0.10% decrease from previous visit or ≥0.15% decrease from baseline; Platelets <50 or >400*10^9/(liter [L]); Prothrombin time 9 seconds above baseline or upper limit of normal range; International normalized ratio >1.7; White blood cells <2.0 or >12.0*10^9/L; Lymphocytes <13.5% or >70%; Glucose, random, serum <2.2 or >16.5 millimole (mmol)/L; Potassium ≤3.0 or ≥5.5 mmol/L; Direct bilirubin increases 3-fold from baseline or >85.5 micromole (umol)/L. Baseline value was defined as the last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

All participants who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

Baseline up to Month 36

ID	Title	Description
OG000	New Rifaximin	Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
OG001	Continuing Rifaximin	Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.

Units	Counts
Participants	OG000252 OG00170

Title

Denominators

Categories

Hemoglobin

- ParticipantsOG000193
- ParticipantsOG00170

Title	Measurements
	OG00015

Primary

Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event

A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

All participants who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

Baseline up to Month 36

ID	Title	Description
OG000	New Rifaximin	Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
OG001	Continuing Rifaximin	Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.

Units	Counts
Participants

Secondary

Number Of Participants With A Significant Mean Change From Baseline In Vital Signs

Vital signs were measured and included sitting blood pressure, heart rate, oral temperature, and weight. These were collected at each scheduled study visit. Participants were placed supine for 5 minutes prior to each assessment of vital signs. Baseline value was defined as last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

All participants who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

Baseline up to Month 36

ID	Title	Description
OG000	New Rifaximin	Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
OG001	Continuing Rifaximin	Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.

Secondary

Change From Baseline In Conn Score At Last Assessment

The assessment for change in mental status during the study was measured by the Conn score (also known as the West Haven score). The following scale was used in the Conn scoring system: Grade 0=No personality or behavioral abnormality detected. Grade 1=Trivial lack of awareness, euphoria, or anxiety; shortened attention span; or impairment of addition or subtraction. Grade 2=Lethargy; disorientation for time; obvious personality change; and inappropriate behavior. Grade 3=Somnolence to semi-stupor, responsive to stimuli; confused; gross disorientation; and bizarre behavior. Grade 4=Coma, unable to test mental state. Participants entered the study with a Conn score of 0 to 2. Baseline value was defined as last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug.

All participants who received at least 1 dose of study drug.

Posted

Mean

Standard Deviation

score on a scale

Baseline up to Month 36

ID	Title	Description
OG000	New Rifaximin	Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
OG001	Continuing Rifaximin	Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment		EG00019 affected252 at risk EG0016 affected70 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0011 affected70 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0004 affected252 at risk EG0011 affected70 at risk
Atrial flutter	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0012 affected70 at risk
Cardiac arrest	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0007 affected252 at risk EG0011 affected70 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0011 affected70 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Pericardial effusion	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Oculogyration	Eye disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0008 affected252 at risk EG0012 affected70 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0011 affected70 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Ascites	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG00015 affected252 at risk EG0012 affected70 at risk
Colitis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Gastroduodenal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0009 affected252 at risk EG0013 affected70 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Ileus	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0003 affected252 at risk EG0011 affected70 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Melaena	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Nausea	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0012 affected70 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0004 affected252 at risk EG0013 affected70 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0011 affected70 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0009 affected252 at risk EG0012 affected70 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Vomiting	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0012 affected70 at risk
Asthenia	General disorders	MedDRA 8.1	Systematic Assessment		EG0005 affected252 at risk EG0011 affected70 at risk
Chest pain	General disorders	MedDRA 8.1	Systematic Assessment		EG0004 affected252 at risk EG0010 affected70 at risk
Death	General disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Drug intolerance	General disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Generalised oedema	General disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0012 affected70 at risk
Gravitational oedema	General disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Oedema	General disorders	MedDRA 8.1	Systematic Assessment		EG0003 affected252 at risk EG0010 affected70 at risk
Oedema peripheral	General disorders	MedDRA 8.1	Systematic Assessment		EG0003 affected252 at risk EG0011 affected70 at risk
Pyrexia	General disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Biliary cirrhosis primary	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG0007 affected252 at risk EG0017 affected70 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG00023 affected252 at risk EG0015 affected70 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Hepatorenal failure	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG0004 affected252 at risk EG0013 affected70 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment		EG0005 affected252 at risk EG0010 affected70 at risk
Cryoglobulinaemia	Immune system disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Liver transplant rejection	Immune system disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Transplant rejection	Immune system disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Abdominal abscess	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Arthritis bacterial	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Bacteraemia	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Biliary abscess	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Biliary tract infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Bronchitis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Campylobacter intestinal infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Candida sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Cellulitis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG00012 affected252 at risk EG0014 affected70 at risk
Cellulitis streptococcal	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Central line infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Clostridial infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Clostridium colitis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0003 affected252 at risk EG0010 affected70 at risk
Diverticulitis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Escherichia sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Fungal peritonitis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Gastroenteritis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Gastrointestinal candidiasis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Lobar pneumonia	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0003 affected252 at risk EG0014 affected70 at risk
Meningitis cryptococcal	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Osteomyelitis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0009 affected252 at risk EG0011 affected70 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Pneumonia	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG00013 affected252 at risk EG0013 affected70 at risk
Postoperative wound infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Respiratory tract infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Scrotal abscess	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0007 affected252 at risk EG0011 affected70 at risk
Sepsis pasteurella	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Septic shock	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0005 affected252 at risk EG0012 affected70 at risk
Skin infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Urinary tract infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0008 affected252 at risk EG0014 affected70 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Viral infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Wound infection	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0011 affected70 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Graft dysfunction	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Open wound	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Renal injury	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0011 affected70 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Shunt stenosis	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Shunt thrombosis	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0011 affected70 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Vena cava injury	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Ammonia increased	Investigations	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Blood potassium decreased	Investigations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Central venous pressure decreased	Investigations	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Transplant evaluation	Investigations	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0005 affected252 at risk EG0010 affected70 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0011 affected70 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Haemochromatosis	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0005 affected252 at risk EG0011 affected70 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG00012 affected252 at risk EG0010 affected70 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0003 affected252 at risk EG0011 affected70 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0011 affected70 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0008 affected252 at risk EG0010 affected70 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0011 affected70 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment		EG0003 affected252 at risk EG0010 affected70 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Biliary neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment		EG00010 affected252 at risk EG0012 affected70 at risk
Liver carcinoma ruptured	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Convulsion	Nervous system disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0012 affected70 at risk
Dizziness	Nervous system disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Encephalopathy	Nervous system disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0011 affected70 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 8.1	Systematic Assessment		EG00079 affected252 at risk EG00118 affected70 at risk
Mental impairment	Nervous system disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Syncope	Nervous system disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Aggression	Psychiatric disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Confusional state	Psychiatric disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Delirium	Psychiatric disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Mental status changes	Psychiatric disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Suicide attempt	Psychiatric disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Renal failure	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment		EG00012 affected252 at risk EG0012 affected70 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment		EG00030 affected252 at risk EG0015 affected70 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0012 affected70 at risk
Renal impairment	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0011 affected70 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0003 affected252 at risk EG0010 affected70 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0011 affected70 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0003 affected252 at risk EG0010 affected70 at risk
Dyspnoea exacerbated	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Hepatopulmonary syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0011 affected70 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0009 affected252 at risk EG0011 affected70 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment		EG0006 affected252 at risk EG0011 affected70 at risk
Penile ulceration	Skin and subcutaneous tissue disorders	MedDRA 8.1	Systematic Assessment	This is a sex-specific adverse event that only affects male participants.	EG0001 affected158 at risk EG0010 affected38 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Liver transplant	Surgical and medical procedures	MedDRA 8.1	Systematic Assessment		EG00022 affected252 at risk EG0017 affected70 at risk
Renal transplant	Surgical and medical procedures	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Peripheral occlusive disease	Vascular disorders	MedDRA 8.1	Systematic Assessment		EG0001 affected252 at risk EG0010 affected70 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 8.1	Systematic Assessment		EG0000 affected252 at risk EG0011 affected70 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment		EG0002 affected252 at risk EG0010 affected70 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment	EG00028 affected252 at risk EG0017 affected70 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment	EG0009 affected252 at risk EG0014 affected70 at risk
Nausea	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG00052 affected252 at risk EG00115 affected70 at risk
Ascites	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG00038 affected252 at risk EG0016 affected70 at risk
Vomiting	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG00034 affected252 at risk EG0018 affected70 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG00030 affected252 at risk EG0018 affected70 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG00029 affected252 at risk EG0019 affected70 at risk
Constipation	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG00033 affected252 at risk EG0014 affected70 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG00015 affected252 at risk EG0015 affected70 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG00013 affected252 at risk EG0017 affected70 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0009 affected252 at risk EG0014 affected70 at risk
Oedema peripheral	General disorders	MedDRA 8.1	Systematic Assessment	EG00048 affected252 at risk EG00113 affected70 at risk
Fatigue	General disorders	MedDRA 8.1	Systematic Assessment	EG00031 affected252 at risk EG0017 affected70 at risk
Pyrexia	General disorders	MedDRA 8.1	Systematic Assessment	EG00014 affected252 at risk EG0016 affected70 at risk
Oedema	General disorders	MedDRA 8.1	Systematic Assessment	EG00017 affected252 at risk EG0012 affected70 at risk
Asthenia	General disorders	MedDRA 8.1	Systematic Assessment	EG00014 affected252 at risk EG0013 affected70 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment	EG0009 affected252 at risk EG0014 affected70 at risk
Urinary tract infection	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG00050 affected252 at risk EG00115 affected70 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG00015 affected252 at risk EG0014 affected70 at risk
Cellulitis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG00016 affected252 at risk EG0011 affected70 at risk
Pneumonia	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG00015 affected252 at risk EG0012 affected70 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0006 affected252 at risk EG0014 affected70 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG00016 affected252 at risk EG0013 affected70 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0008 affected252 at risk EG0015 affected70 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG00037 affected252 at risk EG0018 affected70 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG00015 affected252 at risk EG0016 affected70 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG00015 affected252 at risk EG0015 affected70 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG00013 affected252 at risk EG0016 affected70 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG00013 affected252 at risk EG0013 affected70 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG00010 affected252 at risk EG0015 affected70 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG00010 affected252 at risk EG0014 affected70 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG00030 affected252 at risk EG0018 affected70 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG00023 affected252 at risk EG0015 affected70 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG00010 affected252 at risk EG0016 affected70 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0008 affected252 at risk EG0014 affected70 at risk
Dizziness	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG00025 affected252 at risk EG0017 affected70 at risk
Headache	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG00022 affected252 at risk EG0015 affected70 at risk
Depression	Psychiatric disorders	MedDRA 8.1	Systematic Assessment	EG00030 affected252 at risk EG0019 affected70 at risk
Insomnia	Psychiatric disorders	MedDRA 8.1	Systematic Assessment	EG00030 affected252 at risk EG0014 affected70 at risk
Anxiety	Psychiatric disorders	MedDRA 8.1	Systematic Assessment	EG00015 affected252 at risk EG0018 affected70 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment	EG00013 affected252 at risk EG0011 affected70 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG00031 affected252 at risk EG0017 affected70 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG00018 affected252 at risk EG0015 affected70 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG00014 affected252 at risk EG0012 affected70 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 8.1	Systematic Assessment	EG00020 affected252 at risk EG0013 affected70 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 8.1	Systematic Assessment	EG00019 affected252 at risk EG0014 affected70 at risk
Hypotension	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG00017 affected252 at risk EG0014 affected70 at risk
Hypertension	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG00016 affected252 at risk EG0014 affected70 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases
D001928	Brain Diseases, Metabolic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D047029	Lactams, Macrocyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	New Rifaximin	Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
BG001	Continuing Rifaximin	Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	New Rifaximin	Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.			158	252	212	252
EG001	Continuing Rifaximin	Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.			49	70	52	70