Phase 3 Study to Evaluate the Efficacy and Safety of Elaf... | NCT02704403

NCT02704403

ID	Type	Description	Link
2015-005385-38	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
120 mg Elafibranor	Experimental	Coated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water	Drug: Elafibranor
Placebo	Placebo Comparator	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Elafibranor	Drug		120 mg Elafibranor	GFT505
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis	To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis.	Measurement at 72 weeks
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes	Composite long-term outcome measured by the number of participants with the onset of any of the adjudicated events, composed of death due to any cause, histological liver cirrhosis, and the full list of portal hypertension/cirrhosis related events as follows: liver transplantation; model for end stage liver disease (MELD) score greater than or equal to 15 for participants with baseline score less than or equal to 12, and onset of variceal bleeding requiring hospitalization, hepatic encephalopathy with West Haven/Conn score greater than or equal to 2 and requiring hospitalization, spontaneous bacterial peritonitis, and ascites requiring treatment. The MELD scale ranges from 6 to 40, showing how much a participant needs a liver transplant: higher number is more urgent. The West Haven/Conn scale is 5-point (0 to 4) grading severity of hepatic encephalopathy: higher score means worse hepatic encephalopathy. This outcome measure is for the long-term endpoint analysis.	From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)

Secondary Outcomes

Measure	Description	Time Frame
Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage	To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving improvement of liver fibrosis of at least 1 stage according to NASH Clinical Research Network (CRN) Scoring. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females aged from 18 to 75 years inclusive at first screening visit.
Must provide signed written informed consent and agree to comply with the study protocol.
Females participating in this study must be of nonchildbearing potential or using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment, as described below:
1. Cessation of menses for at least 12 months due to ovarian failure,
2. Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
3. If requested by local IRB regulations and/or National laws, sexual abstinence may be considered adequate (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
4. Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
5. Double contraception with barrier AND highly effective hormonal method of contraception (oral, intravaginal, or transdermal combined estrogen and progestogen hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine hormone-releasing system). The hormonal contraception must be started at least 1 month prior to Randomization.
Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period) with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
NAS score ≥4.
Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy
For participants with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by antidiabetic drugs, change in anti-diabetic therapy must follow these requirements:
1. No qualitative change 6 months prior to diagnostic liver biopsy up to Randomization (i.e., implementation of a new anti-diabetic therapy) for participants treated with metformin, gliptins, sulfonylureas, sodium/glucose cotransporter (SGLT) 2 inhibitors, glucagon-like peptide (GLP)-1 agonists, or insulin. Dose changes of these medications are allowed in the 6 months prior to diagnostic liver biopsy, except for GLP-1 agonists, which must remain on stable dose in the 6 months prior to diagnostic liver biopsy.
2. No implementation of GLP-1 agonists and SGLT2 inhibitors up to 72 weeks of treatment (Visit 7).

Initiation of any other antidiabetic drugs is allowed after Randomization based on treating physicians' judgment, except for glitazones which are prohibited 6 months prior to diagnostic liver biopsy until the end of treatment.

Exclusion Criteria:

Known heart failure (Grade I to IV of New York Heart Association classification).
History of efficient bariatric surgery within 5 years prior to screening.
Uncontrolled hypertension during the Screening Period despite optimal antihypertensive therapy
Type 1 diabetes participants .
Participants with decompensated diabetes (HbA1c>9%).
Participants with a history of clinically significant acute cardiac event within 6 months prior to screening
Weight loss of more than 5% within 6 months prior to randomization
Compensated and decompensated cirrhosis
Current or recent history (<5 years) of significant alcohol consumption
Pregnant or lactating females or females planning to become pregnant during the study period.
Other well documented causes of chronic liver disease according to standard diagnostic procedures
Participants with previous exposure to Elafibranor
Prohibited concomitant medication
Any medical conditions that may diminish life expectancy to less than 2 years including known cancers.
Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Participants with biological criteria exclusion as per effective protocol

Name	Affiliation	Role
Carol Addy, MD MMSc	Genfit	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Digestive Health Specialists of the Southeast

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	120 mg Elafibranor	Coated 120mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
FG001	Placebo	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

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: Local Protocols	Apr 23, 2020

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000138 OG00152

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 OG001	The null hypothesis was that there was no difference in response rates between the elafibranor and placebo treatment groups. The alternative hypothesis was that there was a difference in the response rates between the elafibranor and placebo treatment groups.	Regression, Logistic	test is 2-sided, alpha=0.01	0.0659		Mean Difference (Net)	0.043			2-Sided	95	-0.003	0.090					Superiority

Primary

Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes

Composite long-term outcome measured by the number of participants with the onset of any of the adjudicated events, composed of death due to any cause, histological liver cirrhosis, and the full list of portal hypertension/cirrhosis related events as follows: liver transplantation; model for end stage liver disease (MELD) score greater than or equal to 15 for participants with baseline score less than or equal to 12, and onset of variceal bleeding requiring hospitalization, hepatic encephalopathy with West Haven/Conn score greater than or equal to 2 and requiring hospitalization, spontaneous bacterial peritonitis, and ascites requiring treatment. The MELD scale ranges from 6 to 40, showing how much a participant needs a liver transplant: higher number is more urgent. The West Haven/Conn scale is 5-point (0 to 4) grading severity of hepatic encephalopathy: higher score means worse hepatic encephalopathy. This outcome measure is for the long-term endpoint analysis.

Full Intent-to-Treat Set: All randomized participants. Participants were analyzed according to their randomized treatment.

Posted

Count of Participants

Participants

From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)

ID	Title	Description
OG000	120 mg Elafibranor	Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
OG001

Secondary

Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage

To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving improvement of liver fibrosis of at least 1 stage according to NASH Clinical Research Network (CRN) Scoring. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Intent-to-Treat Set: For the purpose of analysis sets aligned with efficacy summaries, a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early were considered.

Posted

Count of Participants

Participants

Measurements at 72 weeks

ID	Title	Description
OG000	120 mg Elafibranor	Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
OG001	Placebo	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

Secondary

Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

Hemoglobin A1c (HbA1c) were tested at Week 72. Changes from baseline in HbA1c at Week 72 were evaluated. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early. Number of participants with diabetes who had available data at Week 72 are presented.

Posted

Least Squares Mean

95% Confidence Interval

mmol/L

Measurements after 72 weeks of treatment and up to study termination

ID	Title	Description
OG000	120 mg Elafibranor	Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
OG001	Placebo	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

Units	Counts
Participants

Secondary

Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

High-density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

Posted

Least Squares Mean

95% Confidence Interval

mmol/L

Measurements after 72 weeks of treatment and up to study termination

ID	Title	Description
OG000	120 mg Elafibranor	Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
OG001	Placebo	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

Units	Counts
Participants

Secondary

Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

Low-density lipoprotein (LDL) cholesterol was tested at Week 72. Changes from baseline in LDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

Posted

Least Squares Mean

95% Confidence Interval

mmol/L

Measurements after 72 weeks of treatment and up to study termination

ID	Title	Description
OG000	120 mg Elafibranor	Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
OG001	Placebo	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

Units	Counts
Participants

Secondary

Change From Baseline of Homeostatic Model Assessment-IR (HOMA-IR) After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo in Non-diabetic Participants

Homeostatic model assessment-IR (HOMA-IR) was tested at Week 72. Changes from baseline in HOMA-IR were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

Posted

Least Squares Mean

95% Confidence Interval

index

Measurements after 72 weeks of treatment and up to study termination

ID	Title	Description
OG000	120 mg Elafibranor	Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
OG001	Placebo	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

Units	Counts
Participants

Secondary

Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

Non-high density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in non-HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

Posted

Least Squares Mean

95% Confidence Interval

mmol/L

Measurements after 72 weeks of treatment and up to study termination

ID	Title	Description
OG000	120 mg Elafibranor	Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
OG001	Placebo	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

Units	Counts
Participants

Secondary

Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

Triglycerides was tested at Week 72. Changes from baseline in triglycerides were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

Posted

Least Squares Mean

95% Confidence Interval

mmol/L

Measurements after 72 weeks of treatment and up to study termination

ID	Title	Description
OG000	120 mg Elafibranor	Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
OG001	Placebo	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0016 events5 affected717 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0005 affected1,433 at risk EG0010 affected717 at risk
Cardiac failure	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0004 events2 affected1,433 at risk EG0010 affected717 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Angina pectoris	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Angina unstable	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0011 affected717 at risk
Atrial flutter	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0011 affected717 at risk
Cardiac asthma	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 events1 affected1,433 at risk EG0010 affected717 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0012 events1 affected717 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Cardiac arrest	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Coronary artery disease	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Myocardial infarction	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Palpitations	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Prinzmetal angina	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Aplasia	Congenital, familial and genetic disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0011 affected717 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Goitre	Endocrine disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Pituitary-dependent Cushing's syndrome	Endocrine disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Primary hypothyroidism	Endocrine disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Cataract	Eye disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Diplopia	Eye disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Retinal detachment	Eye disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Retinal vein occlusion	Eye disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Vitreous haemorrhage	Eye disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0013 affected717 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0004 affected1,433 at risk EG0011 affected717 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0013 affected717 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0012 affected717 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected1,433 at risk EG0010 affected717 at risk
Ileus	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0012 affected717 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0012 affected717 at risk
Nausea	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Vomiting	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0012 events1 affected717 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0011 affected717 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Appendiceal mucocoele	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Coeliac artery stenosis	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Enteritis	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Gastritis	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Intussusception	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Subileus	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Non-cardiac chest pain	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0005 affected1,433 at risk EG0012 affected717 at risk
Chest pain	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0012 affected717 at risk
Pyrexia	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Asthenia	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Gait disturbance	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Generalised oedema	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Malaise	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Oedema peripheral	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Gallbladder necrosis	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Hepatic haematoma	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Liver injury	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Pneumonia	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0006 affected1,433 at risk EG0015 events3 affected717 at risk
Diverticulitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0005 affected1,433 at risk EG0012 affected717 at risk
Cellulitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected1,433 at risk EG0013 events2 affected717 at risk
Urinary tract infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0013 affected717 at risk
Appendicitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Pyelonephritis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0012 affected717 at risk
Sepsis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Gastroenteritis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0011 affected717 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Device related infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0002 events1 affected1,433 at risk EG0010 affected717 at risk
Abscess limb	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Arthritis bacterial	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Bronchitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
COVID-19	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Cystitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Diverticulitis intestinal perforated	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Endometritis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Gastroenteritis shigella	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Herpes ophthalmic	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Infected bite	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Meningitis aseptic	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Pneumonia influenzal	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Post procedural cellulitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Septic shock	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Shigella sepsis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Superinfection bacterial	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Vascular device infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Viraemia	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0012 affected717 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0012 affected717 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0011 affected717 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0011 affected717 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Bladder injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Chest crushing	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Liver function test increased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0012 affected717 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0012 events1 affected717 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Obesity	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0012 affected717 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0005 affected1,433 at risk EG0013 events2 affected717 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0016 events5 affected717 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0005 events4 affected1,433 at risk EG0011 affected717 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
SLE arthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Vertebral lateral recess stenosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0011 affected717 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected1,433 at risk EG0010 affected717 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0011 affected717 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0011 affected717 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Acute myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
B-cell lymphoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Bile duct adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Intestinal metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Lobular breast carcinoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Ovarian endometrioid carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Papillary renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Tumour of ampulla of Vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Syncope	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0013 affected717 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0004 affected1,433 at risk EG0011 affected717 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Seizure	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Meningocele acquired	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 events1 affected1,433 at risk EG0010 affected717 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Cerebral infarction	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Dizziness	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Encephalopathy	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Facial paralysis	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Headache	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Myasthenia gravis	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Parkinson's disease	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Presyncope	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Pyramidal tract syndrome	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Radiculopathy	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Sciatica	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Spinal cord compression	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Tremor	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Vertebral artery dissection	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Wernicke-Korsakoff syndrome	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Device malfunction	Product Issues	MedDRA (23.1)	Non-systematic Assessment	EG0003 events1 affected1,433 at risk EG0010 affected717 at risk
Device loosening	Product Issues	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 events1 affected1,433 at risk EG0011 affected717 at risk
Major depression	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 events1 affected1,433 at risk EG0010 affected717 at risk
Anxiety disorder	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Behaviour disorder	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Delirium	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Depression	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Depression suicidal	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Drug dependence	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Mental status changes	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Psychiatric decompensation	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected1,433 at risk EG0012 affected717 at risk
Renal colic	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected1,433 at risk EG0010 affected717 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0012 events1 affected717 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0010 affected717 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Haematuria	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Renal failure	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Urinary retention	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Urogenital fistula	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected1,433 at risk EG0010 affected717 at risk
Adnexa uteri mass	Reproductive system and breast disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected1,433 at risk EG0013 affected717 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0004 events2 affected1,433 at risk EG0011 affected717 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0012 affected717 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0012 events1 affected717 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0004 events2 affected1,433 at risk EG0010 affected717 at risk
Hypertension	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 events1 affected1,433 at risk EG0010 affected717 at risk
Aortic dissection	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk
Aortic stenosis	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Haematoma	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected1,433 at risk EG0011 affected717 at risk
Hypotension	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected1,433 at risk EG0010 affected717 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG000171 events148 affected1,433 at risk EG00182 events68 affected717 at risk
Nausea	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG000158 events140 affected1,433 at risk EG00151 events50 affected717 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG000105 events83 affected1,433 at risk EG00149 events47 affected717 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG00094 events79 affected1,433 at risk EG00157 events49 affected717 at risk
Fatigue	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG000111 events103 affected1,433 at risk EG00154 events49 affected717 at risk
Urinary tract infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG000236 events145 affected1,433 at risk EG001134 events77 affected717 at risk
Nasopharyngitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG000186 events134 affected1,433 at risk EG00161 events52 affected717 at risk
Influenza	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG000127 events115 affected1,433 at risk EG00168 events54 affected717 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG000132 events107 affected1,433 at risk EG00155 events46 affected717 at risk
Bronchitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG000111 events93 affected1,433 at risk EG00136 events33 affected717 at risk
Sinusitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG00096 events72 affected1,433 at risk EG00153 events43 affected717 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG000109 events102 affected1,433 at risk EG00162 events58 affected717 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG000202 events160 affected1,433 at risk EG001110 events81 affected717 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG000144 events120 affected1,433 at risk EG00162 events60 affected717 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG00077 events71 affected1,433 at risk EG00127 events25 affected717 at risk
Headache	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG000114 events98 affected1,433 at risk EG00146 events43 affected717 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG00099 events85 affected1,433 at risk EG00147 events40 affected717 at risk
Hypertension	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG00099 events86 affected1,433 at risk EG00142 events39 affected717 at risk

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	120 mg Elafibranor	Coated 120mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
BG001	Placebo	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
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	120 mg Elafibranor	Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	6	1,437	190	1,433	1,227	1,433
EG001	Placebo	Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water	3	720	95	717	601	717