Safety and Efficacy of Selonsertib in Adults With Compens... | NCT03053063

NCT03053063

ID	Type	Description	Link
2016-004148-13	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SEL 6 mg	Experimental	Randomized Phase: SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks. Open-Label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.	Drug: SEL Drug: Placebo to match SEL 18 mg
SEL 18 mg	Experimental	Randomized Phase: SEL 18 mg plus placebo to match SEL 6 mg for up to 240 weeks. Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.	Drug: SEL Drug: Placebo to match SEL 6 mg
Placebo	Placebo Comparator	Randomized Phase: Placebo to match SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks. Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.	Drug: Placebo to match SEL 6 mg Drug: Placebo to match SEL 18 mg

Name	Type	Description	Arm Group Labels	Other Names
SEL	Drug	Tablets administered orally once daily	SEL 18 mg SEL 6 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH	Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.	Week 48
Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event	EFS was assessed by the time to the first clinical event, including liver decompensation events, liver transplantation and all-cause mortality.	Week 240

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240	Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the NAS criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.

Eligibility Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Liver Health		Chandler	Arizona	85224	United States
St. Joseph's Hospital and Medical Center

References Module

Citations

PubMed Identifier	Type	Citation
31271665	Result	Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-Gomez M, Okanoue T, Trauner M, Kersey K, Li G, Han L, Jia C, Wang L, Chen G, Subramanian GM, Myers RP, Djedjos CS, Kohli A, Bzowej N, Younes Z, Sarin S, Shiffman ML, Harrison SA, Afdhal NH, Goodman Z, Younossi ZM. Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials. Hepatology. 2019 Nov;70(5):1521-1530. doi: 10.1002/hep.30842. Epub 2019 Aug 19.
	Result	Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Romero-Gomez M, et al. Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [Poster SAT-273]. European Association for the Study of the Liver (EASL); 2019; Vienna Austria.
30779990

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SEL 18 mg	Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo for up to 240 weeks.
FG001	SEL 6 mg	Randomized Phase: SEL 6 mg tablet orally once daily + placebo for up to 240 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 31, 2018	Mar 20, 2020

Arm/Group Information

ID	Title	Description
BG000	SEL 18 mg	Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks. Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
BG001	SEL 6 mg	Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks. Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
BG002	Placebo	Randomized Phase: Placebo tablet orally once daily for up to 240 weeks. Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH

Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.

The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.

Posted

Number

95% Confidence Interval

percentage of participants

Week 48

ID	Title	Description
OG000	SEL 18 mg	Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks. Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
OG001	SEL 6 mg	Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks. Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
OG002	Placebo	Randomized Phase: Placebo tablet orally once daily for up to 240 weeks. Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.

Units	Counts
Participants	OG000354 OG001351 OG002172

Title

Denominators

Categories

Title	Measurements
	OG00014.4(10.9 to 18.5) OG00112.8(9.5 to 16.8) OG00212.8(8.2 to 18.7)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mantel Haenszel		0.5572	Difference between SEL 18 mg vs Placebo, 95% confidence interval (CI) and p-value were obtained by stratified Mantel-Haenszel method adjusting for baseline (BL) diabetes mellitus status and BL Enhanced Liver Fibrosis (ELF) score (<11.27 vs ≥11.27).	Percentage Difference	1.9			2-Sided	95	-4.4	8.2					Superiority
OG001

Primary

Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event

EFS was assessed by the time to the first clinical event, including liver decompensation events, liver transplantation and all-cause mortality.

No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.

Posted

Week 240

ID	Title	Description
OG000	SEL 18 mg	Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks. Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
OG001	SEL 6 mg	Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks. Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
OG002	Placebo

Secondary

Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240

Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the NAS criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.

No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.

Posted

Week 240

ID	Title	Description
OG000	SEL 18 mg	Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks. Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
OG001	SEL 6 mg	Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks. Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.

Secondary

Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 48

ID	Title	Description
OG000	SEL 18 mg	Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks. Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
OG001	SEL 6 mg	Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks. Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.

Secondary

Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240

No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.

Posted

Week 240

ID	Title	Description
OG000	SEL 18 mg	Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks. Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
OG001	SEL 6 mg	Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks. Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
OG002

Secondary

Percentage of Participants Who Had NASH Resolution at Week 48

NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning reduced to 0 from a value ≥ 1 at baseline; both criteria were necessary conditions. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1.

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 48

ID	Title	Description
OG000	SEL 18 mg	Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks. Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
OG001	SEL 6 mg	Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks. Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.

Secondary

Percentage of Participants Who Had NASH Resolution at Week 240

NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning reduced to 0 from a value ≥ 1 at baseline; both criteria were necessary conditions.As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1.

No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.

Posted

Week 240

ID	Title	Description
OG000	SEL 18 mg	Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks. Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
OG001	SEL 6 mg	Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks. Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SEL 18 mg	Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks.	0	354	60	354	251	354
EG001	SEL 6 mg	Randomized Phase: SEL 6 mg tablet orally once daily + placebo for up to 240 weeks.	0	351	53	351	276	351
EG002	Placebo	Randomized Phase: Placebo tablet orally once daily for up to 240 weeks.	0	172	22	172	135	172
EG003	Open-Label SEL 18 mg	Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.	2	23	7	23	17	23

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected354 at risk EG0013 affected351 at risk EG0021 affected172 at risk EG0030 affected23 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0011 affected351 at risk EG0021 affected172 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0021 affected172 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0012 affected351 at risk EG0020 affected172 at risk EG003
Prinzmetal angina	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected354 at risk EG0012 affected351 at risk EG0020 affected172 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Appendiceal mucocoele	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Gastric polyps	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Gastrointestinal wall thickening	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0012 affected351 at risk EG0021 affected172 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Mesenteric panniculitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Visceral venous thrombosis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Chest pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected354 at risk EG0010 affected351 at risk EG0022 affected172 at risk EG003
Generalised oedema	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0012 affected351 at risk EG0023 affected172 at risk EG003
Peripheral swelling	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0013 affected351 at risk EG0020 affected172 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0021 affected172 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Chronic hepatic failure	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Haemobilia	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Intrahepatic portal hepatic venous fistula	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Sarcoidosis	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Appendicitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Cellulitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected354 at risk EG0013 affected351 at risk EG0020 affected172 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Escherichia pyelonephritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0022 affected172 at risk EG003
Genital herpes	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Meningitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Nasal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Perineal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected354 at risk EG0011 affected351 at risk EG0021 affected172 at risk EG003
Septic shock	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Wound secretion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Blood pressure increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Model for end stage liver disease score increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0012 affected351 at risk EG0021 affected172 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0011 affected351 at risk EG0021 affected172 at risk EG003
Nasal cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0021 affected172 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0012 affected351 at risk EG0021 affected172 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0012 affected351 at risk EG0020 affected172 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Syncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0011 affected351 at risk EG0021 affected172 at risk EG003
Toxic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Endometrial thickening	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Hydrosalpinx	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0011 affected351 at risk EG0020 affected172 at risk EG003
Hepatic hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Haematoma	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected354 at risk EG0010 affected351 at risk EG0021 affected172 at risk EG003
Hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected354 at risk EG0010 affected351 at risk EG0020 affected172 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00022 affected354 at risk EG00122 affected351 at risk EG00212 affected172 at risk EG0033 affected23 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00034 affected354 at risk EG00133 affected351 at risk EG00219 affected172 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00042 affected354 at risk EG00137 affected351 at risk EG00221 affected172 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00046 affected354 at risk EG00147 affected351 at risk EG00218 affected172 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00051 affected354 at risk EG00160 affected351 at risk EG00240 affected172 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00047 affected354 at risk EG00159 affected351 at risk EG00217 affected172 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00024 affected354 at risk EG00128 affected351 at risk EG0027 affected172 at risk EG003
Fatigue	General disorders	MedDRA 21.1	Systematic Assessment	EG00042 affected354 at risk EG00151 affected351 at risk EG00220 affected172 at risk EG003
Oedema peripheral	General disorders	MedDRA 21.1	Systematic Assessment	EG00020 affected354 at risk EG00123 affected351 at risk EG00210 affected172 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00016 affected354 at risk EG00127 affected351 at risk EG00210 affected172 at risk EG003
Influenza	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00027 affected354 at risk EG00124 affected351 at risk EG0028 affected172 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00042 affected354 at risk EG00133 affected351 at risk EG00228 affected172 at risk EG003
Sinusitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00025 affected354 at risk EG00127 affected351 at risk EG00211 affected172 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00043 affected354 at risk EG00152 affected351 at risk EG00215 affected172 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00033 affected354 at risk EG00139 affected351 at risk EG00211 affected172 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG00020 affected354 at risk EG00123 affected351 at risk EG00212 affected172 at risk EG003
Blood creatinine increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 affected354 at risk EG0011 affected351 at risk EG0021 affected172 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00019 affected354 at risk EG00128 affected351 at risk EG00215 affected172 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00034 affected354 at risk EG00130 affected351 at risk EG00216 affected172 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00014 affected354 at risk EG00125 affected351 at risk EG00210 affected172 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00015 affected354 at risk EG00119 affected351 at risk EG0029 affected172 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00016 affected354 at risk EG00119 affected351 at risk EG0025 affected172 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00022 affected354 at risk EG00123 affected351 at risk EG00217 affected172 at risk EG003
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00047 affected354 at risk EG00148 affected351 at risk EG00221 affected172 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected354 at risk EG0015 affected351 at risk EG0022 affected172 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG00024 affected354 at risk EG00128 affected351 at risk EG0027 affected172 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00027 affected354 at risk EG00133 affected351 at risk EG00214 affected172 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected354 at risk EG0018 affected351 at risk EG0022 affected172 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG00029 affected354 at risk EG00127 affected351 at risk EG00211 affected172 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG00019 affected354 at risk EG00113 affected351 at risk EG00210 affected172 at risk EG003

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases