Study of Efficacy and Safety of LCZ696 in Japanese Patien... | NCT02468232

Label	Type	Description	Intervention Names
LCZ696	Experimental	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.	Drug: LCZ696 Drug: Placebo to Enalapril
Enalapril	Active Comparator	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.	Drug: Enalapril Drug: Placebo to LCZ696

Name	Type	Description	Arm Group Labels	Other Names
LCZ696	Drug	The target dose during the study was LCZ696 200 mg bid given orally. LCZ696 was supplied as 50 mg, 100 mg and 200 mg film-coated tablets.	LCZ696

Measure	Description	Time Frame
Number of Participants Who Had CEC (Clinical Endpoint Committee) Confirmed Composite Endpoints	Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. The composite endpoint events occurred on and after End-of-study (EOS) declaration were reported by investigators but those events were not required to be adjudicated by Clinical Endpoint Committee (CEC) and not included in the efficacy analysis.	up to 40 months
Exposure-adjusted Incident Rate (EAIR) of CEC Confirmed Composite Endpoints	Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. EAIR = n/T where n = Total number of events included in the analysis. T (100 patient years) = total up-to-event/censoring duration-time summarized over participants in the respective treatment group. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.	up to 40 months

Measure	Description	Time Frame
Key Secondary: Change From Baseline to the Pre-defined Time-points in Log-transformed Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)	NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Change from baseline to the pre-defined time-points in logarithmic scale were analyzed using a repeated measures ANCOVA model with treatment, the stratification factor screening NT-proBNP classification recorded in the Interactive Web Response System (IWRS), visit and treatment-by-visit interaction as fixed effect factors and the logarithmic baseline biomarker value as a covariate, with a common unstructured covariance matrix among visits for each treatment. The analysis is using all available data up to month 6 based on likelihood method with an assumption of missing at random (MAR) for missing data. This record summarizes the estimates of ratio Post-baseline /Baseline NT-proBNP.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Nagoya	Aichi-ken	453-8511	Japan
Novartis Investigative Site

ID	Title	Description
FG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 19, 2018	Feb 17, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Had CEC (Clinical Endpoint Committee) Confirmed Composite Endpoints

Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. The composite endpoint events occurred on and after End-of-study (EOS) declaration were reported by investigators but those events were not required to be adjudicated by Clinical Endpoint Committee (CEC) and not included in the efficacy analysis.

Posted

Count of Participants

Participants

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG002	LCZ696 (Core) OLE Epoch	The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.
OG003	Enalapril (Core) OLE Epoch	The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.

Units	Counts
Participants	OG000111 OG001112 OG0020 OG003

Title

Denominators

Categories

Primary composite

Title	Measurements
	OG00030 OG00128 OG0020 OG003

Primary

Exposure-adjusted Incident Rate (EAIR) of CEC Confirmed Composite Endpoints

Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. EAIR = n/T where n = Total number of events included in the analysis. T (100 patient years) = total up-to-event/censoring duration-time summarized over participants in the respective treatment group. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.

Posted

Number

95% Confidence Interval

Events per 100 patient-years

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Key Secondary: Change From Baseline to the Pre-defined Time-points in Log-transformed Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Change from baseline to the pre-defined time-points in logarithmic scale were analyzed using a repeated measures ANCOVA model with treatment, the stratification factor screening NT-proBNP classification recorded in the Interactive Web Response System (IWRS), visit and treatment-by-visit interaction as fixed effect factors and the logarithmic baseline biomarker value as a covariate, with a common unstructured covariance matrix among visits for each treatment. The analysis is using all available data up to month 6 based on likelihood method with an assumption of missing at random (MAR) for missing data.

This record summarizes the estimates of ratio Post-baseline /Baseline NT-proBNP.

This analysis is a longitudinal data analysis and all available data up to month 6 for each patient was used. Number of participants at each post-time point indicates the number of patients who have both baseline and post-time point values.

Posted

Geometric Mean

95% Confidence Interval

ratio

Baseline, Weeks 4, 8 and Month 6

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Key Secondary: Number of Participants With CEC-confirmed First Triple Composite Endpoint (Cardiovascular (CV) Death, Heart Failure (HF) Hospitalization, or Worsening of HF in Outpatients)

Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. Worsening HF defined as: worsening signs and symptoms of HF requiring addition of a new drug for HF treatment, initiation of IV treatment, increase of diuretic dose for persistent use for ≥4 consecutive weeks, or institution of mechanical or circulatory support such as mechanical ventilation, ultrafiltration, hemodialysis, intra-aortic balloon pump or ventricular assist device. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.

Posted

Count of Participants

Participants

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Key Secondary: EAIR of CEC-confirmed First Triple Composite Endpoint (Cardiovascular (CV) Death, Heart Failure (HF) Hospitalization, or Worsening of HF in Outpatients)

Worsening HF defined as: worsening signs and symptoms of HF requiring addition of a new drug for HF treatment, initiation of IV treatment, increase of diuretic dose for persistent use for ≥4 consecutive weeks, or institution of mechanical or circulatory support such as mechanical ventilation, ultrafiltration, hemodialysis, intra-aortic balloon pump or ventricular assist device.

EAIR(Exposure-adjusted incidence rate per 100 patient years)= n/T:

n: Total number of events included in the analysis. T(100 patient years): total up-to-event/censoring duration-time summarized over patients in the respective treatment group. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.

Posted

Number

95% Confidence Interval

Events per 100 patient-years

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Key Secondary: Number of Participants by Changes in New York Heart Association (NYHA) Classification From Baseline at Predefined Timepoints

NYHA classification is a subjective physician's assessment of heart failure patient's functional capacity and symptomatic status.

Class I - No limitation of physical activity. Class II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

The NYHA class change was analyzed as a three category ordinal variable with levels: "improved", "unchanged", and "worsened", defined by at least one class improvement, no change, at least one class worsening, in NYHA class, respectively. NYHA class after patients who died was categorized into "worsened".

FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. Number of participants at post-time point (i.e., n) indicates the number of patients who have post-time point values.

Posted

Count of Participants

Participants

Baseline, Weeks 4, 8 and Month 6

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Key Secondary: Change From Baseline in Clinical Summary Score for Heart Failure Symptoms and Physical Limitations Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ).

The KCCQ is a self-administered questionnaire and requires, on average, 4-6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL), each with different Likert scaling wording, including limitations, frequency, bother, change in condition, understanding, etc. The clinical summary score is a mean of the physical limitation and total symptom scores. The total symptom score is the mean of the symptom frequency and symptom burden scores. Each scale score (the physical limitation, symptom frequency or symptom burden) is calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents dead. A change of 5 points on the scale scores, either as a group mean difference or an intra-individual change appears to be clinically significant.

FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. FAS included all patients with at least one KCCQ data. This is a longitudinal data analysis and all available data for each patient was used. Number of patients at each post-time point (n) indicates the number of patients who have both baseline and post-time point values.

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline, Week 8 and Month 6

ID	Title	Description
OG000	LCZ696

Secondary

Total Number of CEC Confirmed Composite of CV Death and Total (First and Recurrent) HF Hospitalizations for Heart Failure

Total number of CEC-confirmed CV death and total (first and recurrent) HF hospitalizations per patient was analyzed using the negative binomial regression model. CV deaths and HF hospitalizations occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.

Posted

Number

95% Confidence Interval

Events per patient

up tp 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Number of Participants by Changes in Clinical Composite Score (as Assessed by NYHA Classification and Patient Global Assessment) at Predefined Timepoints

The global assessment was derived from the 7-category classification of the global assessment of disease activity to a three-category classification: Improved (Markedly improved; moderately improved), Unchanged (Slightly improved, unchanged, slightly worsened), and Worsened (Moderately worsened, markedly worsened).

The clinical composite assessment was defined as follows:

Improved: 1) If NYHA class decreased at least one level and Global Assessment was not worse at the selected visit and there was no major AE up to the selected visit; or 2) Global assessment was improved and NYHA class did not increase at the selected visit, and there was no major AE up to the selected visit.
Worsened: 1) If NYHA class increased at the selected visit; or 2) Global Assessment was worse at the selected visit; or 3) experienced a major AE up to the selected visit.
Unchanged: If neither "Improved" nor "Worsened".

The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. Overall Number of Participants Analyzed' indicates the number of patients who have post-time point values.

Posted

Count of Participants

Participants

Baseline, Month 6

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Number of Participants With All-cause Mortality

The number of participants who died due to any cause. Deaths occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.

Posted

Count of Participants

Participants

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

EAIR of All-cause Mortality

EAIR (Exposure-adjusted incidence rate per 100 patient years)= n/T:

n: Total number of events included in the analysis. T(100 patient years): total up-to-event/censoring duration-time summarized over patients in the respective treatment group. Deaths occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.

Posted

Number

95% Confidence Interval

Events per 100 patient-years

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Percentage of Participants Hospitalized

Percentage of participants with hospitalized admissions

Posted

Count of Participants

Participants

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG002	LCZ696 (Core) OLE Epoch

Secondary

Hospitalization Admissions Events Per-participant Per Year

The number of hospital admission events per-participant per year was calculated as total number of hospital admission divided by total up-to-event/censoring duration-time summarized over patients.

Posted

Number

95% Confidence Interval

Hospitalization admissions per year

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Days in Intensive Care Unit (ICU) Per Participant Per Year

The number of days in ICU per participant per year was calculated as total number of days in ICU divided by total up-to-event/censoring duration-time summarized over patients.

Posted

Number

95% Confidence Interval

Days per year

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Percentage of Re-hospitalizations

The percentage of participants who had re-hospitalizations.

Posted

Count of Participants

Participants

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG002	LCZ696 (Core) OLE Epoch

Secondary

Emergency Department/Urgent Care Facility Visits for HF Per Patient Per Year

The number of emergency department/urgent care facility visits for HF per patient per year was calculated as total number of emergency department/urgent care facility visits for HF divided by total up-to-event/censoring duration-time summarized over patients.

Posted

Number

95% Confidence Interval

Visits per year

up to 40 months

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Change in Blood NT-proBNP From Baseline

NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Mean change from baseline (post-baseline value - baseline value) in plasma NT-proBNP was caluculated.

The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. Number of participants at each post-time point (i.e., n) indicates the number of patients who have both baseline and post-time point values.

Posted

Mean

Standard Deviation

pg/mL

Baseline, Weeks 2, 4, 8 and Month 6

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Change in Procollagen Type III N-Terminal Propeptide From Baseline

Procollagen Type III N-Terminal Propeptide (PIIINP) is a serum marker of collagen turnover, generated during the synthesis of type III collagen. Increased circulating PIIINP is a marker not only of muscle growth, but also of muscle repair and fibrosis. Mean change from baseline (post-baseline value - baseline value) in serum PIIINP was calculated.

Posted

Mean

Standard Deviation

ug/L

Baseline and Month 18

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Changes in Urine Cyclic Guanosine 3',5'-Monophosphate (cGMP) From Baseline

Urinary Cyclic GMP (cGMP) is a biomarker measured in the urine that reflects the activity of biomarkers such as BNP (Brain Natriuretic Peptide). First morning void (FMV) urine samples were collected. Mean change from baseline (post-baseline value - baseline value) in urine cGMP was calculated.

Posted

Mean

Standard Deviation

nmol/L

Baseline, Weeks 4, 8 and Month 6

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Percentage of Participants Reaching Target Dose Level 3 at Week 8 and Maintained at Month 4 (Open Label Extension (OLE))

The percentage of participants who reached target dose level (200 mg b.i.d.) at Week 8 and maintained at Month 4(OLE). This indicates how tolerabile to LCZ696 at target dose.

FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.

Posted

Count of Participants

Participants

Month 4 of OLE

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Change in NYHA Classification From OLE Baseline (OLE)

NYHA classification is a subjective physician's assessment of heart failure patient's functional capacity and symptomatic status.

FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.

Posted

Count of Participants

Participants

OLE Baseline, Month 12 (OLE)

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Change in Key Echocardiographic Parameters From OLE Baseline at Month 12 (OLE)

Key echocardiographic parameters:

LAVi- left atrial volume index, LVEDVi- left ventricular end diastolic volume index, LVESVi- left ventricular end systolic volume index.

A two-dimensional and doppler echo examination was done to assess echo parameters. Mean changes from baseline (post-baseline value - baseline value) in each parameter were calculated. A negative change from baseline indicates improvement.

FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.

Posted

Mean

Standard Deviation

mL/m^2

Baseline, Month 12 (OLE)

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Change in Cardiac Measurements by Key Echocardiographic Parameter LVEF, From OLE Baseline at Month 12 (OLE)

Key echocardiographic parameter:

LVEF- left ventricular ejection fraction. LVEF is a measurement expressed as a percentage of how much blood the left ventricle pumps out with each contraction. Mean changes from baseline (post-baseline value - baseline value) in LVEF were calculated.

FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.

Posted

Mean

Standard Deviation

Percentage of ejected blood

Baseline, Month 12 (OLE)

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Change in B-type Natriuretic Peptide (BNP) From OLE Baseline to Predefined Timepoints (OLE)

BNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Mean change from baseline (post-baseline value - OLE baseline value) in plasma BNP was calculated.

FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.

Number of participants at each post-time point (i.e., n) indicates the number of patients who have both baseline and post-time point values.

Posted

Mean

Standard Deviation

pg/mL

Baseline, Weeks 2-4, Week 8, Months 4 and 12 (OLE)

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From OLE Baseline to Predefined Timepoints (OLE)

NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Mean change from baseline (post-baseline value - OLE baseline value) in plasma NT-proBNP was calculated.

FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.

Number of participants at each post-time point (i.e., n) indicates the number of patients who have both baseline and post-time point values.

Posted

Mean

Standard Deviation

pg/mL

Baseline, Weeks 2-4, Week 8, Months 4 and 12 (OLE)

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Change in Urine cGMP From OLE Baseline to Predefined Timepoints (OLE)

Urinary Cyclic GMP (cGMP) is a biomarker measured in the urine that reflects the activity of biomarkers such as BNP (Brain Natriuretic Peptide). Spot urine samples were collected. Mean change from baseline (post-baseline value - OLE baseline value) in urine cGMP was calculated.

FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug. Number of participants at each post-time point (i.e., n) indicates the number of patients who have both baseline and post-time point values.

Posted

Mean

Standard Deviation

nmol/L

Weeks 2-4, Week 8, Months 4 and 12 (OLE)

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Secondary

Association Between Change in NT-proBNP Concentration and Change in Echocardiographic Parameters From OLE Baseline at Month 12 (OLE)

Association (using the Pearson correlation coefficient) between change from OLE baseline in log-transformed NT-proBNP and echocardiographic parameters (LAVi, LVEDVi, LVESVi & LVEF)

Posted

Number

95% Confidence Interval

Peason's correlation

Month 12

ID	Title	Description
OG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
OG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG0030 affected71 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Acute cardiac event	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0014 affected112 at risk EG0022 affected79 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Cardiac dysfunction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG00018 affected111 at risk EG00122 affected112 at risk EG00217 affected79 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0006 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0005 affected111 at risk EG0014 affected112 at risk EG0020 affected79 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cardiac sarcoidosis	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pericarditis	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0014 affected112 at risk EG0022 affected79 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0014 affected112 at risk EG0022 affected79 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cataract	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0005 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Hyalosis asteroid	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Maculopathy	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Retinal detachment	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0005 affected111 at risk EG0012 affected112 at risk EG0022 affected79 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Complication associated with device	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Death	General disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Malaise	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pyrexia	General disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Sudden cardiac death	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Sudden death	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Vascular stent stenosis	General disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cholecystocholangitis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Hepatorenal failure	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Bronchitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cellulitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Device related infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Influenza	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Intervertebral discitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Peritonsillar abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pneumonia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0006 affected111 at risk EG0012 affected112 at risk EG0024 affected79 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Septic shock	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Wound infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Heat illness	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0022 affected79 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0013 affected112 at risk EG0022 affected79 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Marasmus	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cerebellar infarction	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0015 affected112 at risk EG0022 affected79 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Parkinsonism	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Presyncope	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Sciatica	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Spondylitic myelopathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Syncope	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Nephropathy	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Scrotal oedema	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Ischaemic skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Arterial stenosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Hypotension	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Peripheral artery occlusion	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Varicose vein	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG00011 affected111 at risk EG00111 affected112 at risk EG0026 affected79 at risk EG0032 affected71 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0013 affected112 at risk EG0023 affected79 at risk EG003
Polycythaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0006 affected111 at risk EG0015 affected112 at risk EG0024 affected79 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cardiac dysfunction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG00024 affected111 at risk EG00125 affected112 at risk EG00210 affected79 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Palpitations	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0014 affected112 at risk EG0023 affected79 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0005 affected111 at risk EG0017 affected112 at risk EG0026 affected79 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Rathke's cleft cyst	Congenital, familial and genetic disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Deafness neurosensory	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Eustachian tube patulous	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
External ear pain	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Goitre	Endocrine disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Thyroid disorder	Endocrine disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Blepharitis	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Blepharochalasis	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cataract	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0008 affected111 at risk EG0018 affected112 at risk EG0021 affected79 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0014 affected112 at risk EG0020 affected79 at risk EG003
Diabetic retinal oedema	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Dry eye	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Erythema of eyelid	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Eye discharge	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Eye pain	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Eyelid oedema	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Glaucoma	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Macular fibrosis	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Macular oedema	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Mydriasis	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Orbital myositis	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Posterior capsule opacification	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Retinal vein occlusion	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Rhegmatogenous retinal detachment	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Visual impairment	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Vitreous floaters	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0015 affected112 at risk EG0020 affected79 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Barrett's oesophagus	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG00014 affected111 at risk EG00118 affected112 at risk EG0026 affected79 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0015 affected112 at risk EG0022 affected79 at risk EG003
Dental cyst	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG00019 affected111 at risk EG00117 affected112 at risk EG0024 affected79 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Dyschezia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Faeces hard	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Gastric polyps	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Gastrointestinal angiectasia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Gingival swelling	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Intestinal mass	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0006 affected111 at risk EG0013 affected112 at risk EG0022 affected79 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0005 affected111 at risk EG0015 affected112 at risk EG0021 affected79 at risk EG003
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Parotid gland enlargement	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Rectal perforation	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Rectal polyp	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Reflux gastritis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Stomach mass	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Tongue discomfort	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Tongue haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Tongue ulceration	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Varices oesophageal	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0014 affected112 at risk EG0022 affected79 at risk EG003
Asthenia	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Catheter site erythema	General disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Catheter site phlebitis	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Chest discomfort	General disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Chest pain	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Chills	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Disuse syndrome	General disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Face oedema	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Fatigue	General disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Inflammation	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Infusion site extravasation	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Malaise	General disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Oedema peripheral	General disorders	MedDRA (23.1)	Systematic Assessment	EG0005 affected111 at risk EG0013 affected112 at risk EG0023 affected79 at risk EG003
Peripheral swelling	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Pneumatosis	General disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Puncture site pain	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Pyrexia	General disorders	MedDRA (23.1)	Systematic Assessment	EG0007 affected111 at risk EG0018 affected112 at risk EG0023 affected79 at risk EG003
Surgical failure	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Thirst	General disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Alcoholic liver disease	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Congestive hepatopathy	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Hepatic congestion	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0007 affected111 at risk EG0018 affected112 at risk EG0025 affected79 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Food allergy	Immune system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Graft versus host disease	Immune system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Sarcoidosis	Immune system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Abscess jaw	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Abscess neck	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Bacterial infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Bronchitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0018 affected112 at risk EG0022 affected79 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cellulitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0014 affected112 at risk EG0020 affected79 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cystitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Dermatophytosis of nail	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0022 affected79 at risk EG003
Device related infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Empyema	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Endocarditis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Enterocolitis viral	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Erysipelas	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Focal peritonitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0017 affected112 at risk EG0021 affected79 at risk EG003
Gastroenteritis clostridial	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Gastroenteritis norovirus	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Genital herpes zoster	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Gingivitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Helicobacter gastritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0006 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Hordeolum	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Infected dermal cyst	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Influenza	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0008 affected111 at risk EG0017 affected112 at risk EG0021 affected79 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG00053 affected111 at risk EG00153 affected112 at risk EG00219 affected79 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Oral herpes	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Otitis externa	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Paronychia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Parotitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Periodontitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0015 affected112 at risk EG0021 affected79 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Pneumonia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0019 affected112 at risk EG0022 affected79 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Post procedural infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Rhinitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Septic shock	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Sinusitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Skin bacterial infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Skin candida	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Systemic mycosis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Tinea infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Tinea pedis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0007 affected111 at risk EG0010 affected112 at risk EG0023 affected79 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Tooth infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Toxic shock syndrome	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Trichophytosis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0015 affected112 at risk EG0021 affected79 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Vulval abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Arterial injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Bone contusion	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Bone fissure	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Burns first degree	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Chillblains	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0006 affected111 at risk EG00110 affected112 at risk EG0023 affected79 at risk EG003
Dental restoration failure	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Face injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0007 affected111 at risk EG0011 affected112 at risk EG0023 affected79 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Foreign body in eye	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Heat illness	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hyphaema	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Nasal injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0015 affected112 at risk EG0020 affected79 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Traumatic lung injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Urethral injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Wound complication	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Blood bilirubin increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Blood glucose increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Blood potassium decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Blood potassium increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Blood pressure decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG00010 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Blood pressure increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Blood pressure systolic decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Blood sodium increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Blood thyroid stimulating hormone decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Blood urea decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Blood urea increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Blood uric acid decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Blood urine present	Investigations	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Brain natriuretic peptide increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
C-reactive protein increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Electrocardiogram QRS complex prolonged	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Eosinophil count increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Helicobacter test positive	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Hepatic enzyme abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
High density lipoprotein decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
International normalised ratio increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Lipids abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Liver function test abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Liver function test increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Occult blood	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Platelet count decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Prothrombin time abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Renal function test abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
SARS-CoV-2 test negative	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Tri-iodothyronine free decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Urine output decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Weight decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0005 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Weight increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0014 affected112 at risk EG0022 affected79 at risk EG003
White blood cell count decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
White blood cell count increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG00017 affected111 at risk EG0018 affected112 at risk EG0021 affected79 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0006 affected111 at risk EG00110 affected112 at risk EG0025 affected79 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG00013 affected111 at risk EG00117 affected112 at risk EG0025 affected79 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG00010 affected111 at risk EG0016 affected112 at risk EG0022 affected79 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hypochloraemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0015 affected112 at risk EG0020 affected79 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG00011 affected111 at risk EG0019 affected112 at risk EG0026 affected79 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Hypovitaminosis	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Zinc deficiency	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0017 affected112 at risk EG0023 affected79 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0023 affected79 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG00011 affected111 at risk EG00116 affected112 at risk EG0023 affected79 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Jaw disorder	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0022 affected79 at risk EG003
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Nodal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0010 affected112 at risk EG0022 affected79 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0012 affected112 at risk EG0022 affected79 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Spinal deformity	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0022 affected79 at risk EG003
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0022 affected79 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Altered state of consciousness	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Brain oedema	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cerebral artery occlusion	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cerebral disorder	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cervicobrachial syndrome	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Dementia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Dizziness	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG00011 affected111 at risk EG0017 affected112 at risk EG0021 affected79 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Dystonia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Head discomfort	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Headache	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0017 affected112 at risk EG0021 affected79 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0022 affected79 at risk EG003
Monoplegia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Myelopathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Neuralgia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Parosmia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Postresuscitation encephalopathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Presyncope	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Sciatica	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Somnolence	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Syncope	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Tension headache	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Trigeminal neuralgia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Device occlusion	Product Issues	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Adjustment disorder	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Anxiety disorder	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Delirium	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0013 affected112 at risk EG0022 affected79 at risk EG003
Depression	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Eating disorder	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Gambling disorder	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG00010 affected111 at risk EG00110 affected112 at risk EG0024 affected79 at risk EG003
Restlessness	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Bladder spasm	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Cystitis noninfective	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Diabetic nephropathy	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Hypertonic bladder	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Nephropathy	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Neurogenic bladder	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Prerenal failure	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Renal disorder	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG00018 affected111 at risk EG00123 affected112 at risk EG00211 affected79 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Genital erosion	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Genital erythema	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Allergic bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0014 affected112 at risk EG0020 affected79 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Combined pulmonary fibrosis and emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0008 affected111 at risk EG00111 affected112 at risk EG0027 affected79 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0008 affected111 at risk EG0014 affected112 at risk EG0023 affected79 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0012 affected112 at risk EG0021 affected79 at risk EG003
Laryngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0005 affected111 at risk EG0013 affected112 at risk EG0023 affected79 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Sputum retention	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0006 affected111 at risk EG0016 affected112 at risk EG0020 affected79 at risk EG003
Vocal cord inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Asteatosis	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Cholestatic pruritus	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Chronic pigmented purpura	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0014 affected112 at risk EG0021 affected79 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0003 affected111 at risk EG0015 affected112 at risk EG0021 affected79 at risk EG003
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0007 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Epidermal necrosis	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Keloid scar	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Milia	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Penile ulceration	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0006 affected111 at risk EG0015 affected112 at risk EG0020 affected79 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0013 affected112 at risk EG0021 affected79 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Senile pruritus	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Skin erosion	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0021 affected79 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0013 affected112 at risk EG0020 affected79 at risk EG003
Urticaria chronic	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0010 affected112 at risk EG0020 affected79 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Hypertension	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0004 affected111 at risk EG0018 affected112 at risk EG0022 affected79 at risk EG003
Hypotension	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG00027 affected111 at risk EG00110 affected112 at risk EG0029 affected79 at risk EG003
Internal haemorrhage	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0002 affected111 at risk EG0012 affected112 at risk EG0020 affected79 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0001 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0010 affected112 at risk EG0021 affected79 at risk EG003
Varicose vein	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected111 at risk EG0011 affected112 at risk EG0020 affected79 at risk EG003

ID	Term
D004151	Dipeptides
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description
BG000	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.
BG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.
BG002	LCZ696 (Core) OLE Epoch	The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.
BG003	Enalapril (Core) OLE Epoch	The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.
BG004	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	LCZ696	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.	20	111	64	111	108	111
EG001	Enalapril	Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.	17	112	61	112	108	112
EG002	LCZ696 (Core) OLE Epoch	The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.	4	79	38	79	67	79
EG003	Enalapril (Core) OLE Epoch	The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.	3	71	26	71	64	71

ID	Term
C549068	sacubitril and valsartan sodium hydrate drug combination
D004656	Enalapril