A Phase 3 Clinical Outcomes Study to Compare the Incidenc... | NCT02145468

NCT02145468

Status Module

Name	Class
The TIMI Study Group	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Losmapimod	Experimental	Losmapimod 7.5 mg twice daily oral tablet	Drug: Losmapimod 7.5 mg twice daily Drug: Standard therapy
Placebo	Placebo Comparator	Placebo twice daily oral tablet	Drug: Placebo twice daily Drug: Standard therapy

Name	Type	Description	Arm Group Labels	Other Names
Losmapimod 7.5 mg twice daily	Drug	Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.	Losmapimod

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12	The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths.	Up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With First Occurrence of MACE Through Week 24	Number of participants with first occurrence of MACE through Week 24 including CV death, MI or SRI-UR are presented. Death for which the CEC or investigator were unable to establish cause were analyzed as CV deaths.	Up to Week 24
Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent
Men or women at least 35 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy
Hospitalization for NSTEMI or STEMI (Universal Definition Type 1 MI)
With the following timing of symptoms: NSTEMI: Presence of ischemic symptoms (>=5 minutes) at rest within 24 hours prior to randomization (may include qualifying episode). STEMI: Onset of qualifying ischemic symptoms within 12 hours of randomization.
At least one of the following
Age >=60 years at randomization.
Myocardial infarction prior to the qualifying ACS event
CABG prior to qualifying ACS event.
NSTEMI with new ischemic ST-segment depression >= 0.1 mV in >= 2 contiguous leads.
Diabetes mellitus requiring pharmacotherapy.
Coexistent clinically diagnosed arterial disease

Exclusion Criteria:

Unable to be randomized prior to coronary revascularization or fibrinolysis for the qualifying MI.
Current severe heart failure or shock
Ongoing clinical instability
History of chronic liver disease
Known severe renal impairment
Any condition, other than vascular disease, with life expectancy <1 year that might prevent the subject from completing the study.
Known active tuberculosis, HIV, active opportunistic or life threatening infections.
Vaccination with a live attenuated vaccine within 6 weeks of randomization.
Concomitant use of cytotoxic chemotherapy for cancer or known ongoing or anticipated use of chronic severe immunosuppressive agents
Positive pregnancy test or is known to be pregnant or lactating
Known alcohol or drug abuse within the past 6 months
Any current mental condition, which may affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study.
Participation in a study of an investigational medication within the past 30 days.
Anticipated inability to comply with any study procedures, including participation in study visits according to the visit schedule through 24 weeks.
Use of another investigational product within 30 days or 5 half-lives (whichever is longer) or according to local regulations, or currently participating in a study of an investigational device. Subjects must be randomized only one time in this investigational study
Any other reason the investigator deems the subject to be unsuitable for the study

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Huntsville	Alabama	35801	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34508693	Derived	Cavender MA, O'Donoghue ML, Abbate A, Aylward P, Fox KA, Glaser RX, Park JG, Lopez-Sendon J, Steg PG, Sabatine MS, Morrow DA. Inhibition of p38 MAP kinase in patients with ST-elevation myocardial infarction - findings from the LATITUDE-TIMI 60 trial. Am Heart J. 2022 Jan;243:147-157. doi: 10.1016/j.ahj.2021.08.022. Epub 2021 Sep 8.
27043082

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
116197	Statistical Analysis Plan	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, twice daily (BID), according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
BG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00066.5± 9.72 BG00166.7± 10.00 BG00266.6± 9.86

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000532 BG001500 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0008 BG0018 BG002

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 With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12

The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths.

Intent-To-Treat (ITT) Population. ITT population comprised of all randomized participants.

Posted

Number

Participants

Up to 12 weeks

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants	OG0001758 OG0011731

Title

Denominators

Categories

First occurence of MACE

Title	Measurements
	OG000123 OG001139

CV Death

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.238		Hazard Ratio (HR)	1.16			2-Sided	95	0.91	1.47			Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.		Superiority

Secondary

Number of Participants With First Occurrence of MACE Through Week 24

Number of participants with first occurrence of MACE through Week 24 including CV death, MI or SRI-UR are presented. Death for which the CEC or investigator were unable to establish cause were analyzed as CV deaths.

ITT Population.

Posted

Number

Participants

Up to Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24

Week 12 results are considered the principal secondary endpoint. Number of participants with first occurrence of the composite of CV death or MI up to Week 12 and Week 24 are summarized.

ITT Population

Posted

Number

Participants

Week 12 and Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Composite of CV Death, MI or Hospitalization for Heart Failure (HF) up to Week 12 and Week 24.

Number of participants with first occurrence of the composite of CV death, MI or hospitalization for HF up to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12 and Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Expanded Composite of Arterial CV Events Defined as CV Death, MI, SRI-UR or Stroke Through to Week 12 and Week 24

Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Composite of Coronary Events Defined as CHD Death, MI, SRI-UR or Any Unplanned Coronary Artery Revascularization Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of coronary events defined as coronary heart disease (CHD) death, MI, SRI-UR or any unplanned coronary artery revascularization through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts

Secondary

Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Expanded Composite of CV Death, MI, SRI-UR, Stroke or Hospitalization for HF Through to Week 12 and Week 24

Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Composite of CV Death, Type I (Spontaneous) MI or SRI-UR Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24

Number of participants with first occurrence of definite or probable stent thrombosis through to Week 12 and Week 24 are presented. Participants receiving stent prior to randomization or during the study prior to Week 12 were included.

ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, in the category titles).

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts

Secondary

Number of Participants Re-hospitalized Within 30 Days of Discharge

Participants who had a death or re-hospitalization within 30 days of discharge, plus participants who were never discharged from the initial hospitalization were included.

ITT Population

Posted

Number

Participants

Within up to 30 days of post discharge

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With All-cause Mortality Through to Week 12 and Week 24

Number of participants with all-cause mortality through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With CV Death Events Through to Week 12 and Week 24

Number of participants with CV death events through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With CHD Death Events Through to Week 12 and Week 24

Number of participants with CHD death events through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and Week 24

Number of participants with first occurrence of myocardial infarction (fatal and non-fatal) events through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24

Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24

Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24

Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24

Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24

Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24 are presented.

ITT Population

Posted

Number

Participants

Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
OG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.	68	1,752	323	1,752	370	1,752
EG001	Losmapimod 7.5 mg BID	Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.	57	1,724	363	1,724	376	1,724

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	18.1	Systematic Assessment	EG00024 affected1,752 at risk EG00126 affected1,724 at risk
Angina pectoris	Cardiac disorders	18.1	Systematic Assessment	EG00014 affected1,752 at risk EG00124 affected1,724 at risk
Atrial fibrillation	Cardiac disorders	18.1	Systematic Assessment	EG00014 affected1,752 at risk EG00119 affected1,724 at risk
Acute myocardial infarction	Cardiac disorders	18.1	Systematic Assessment	EG0007 affected1,752 at risk EG00113 affected1,724 at risk
Cardiac failure	Cardiac disorders	18.1	Systematic Assessment	EG0006 affected1,752 at risk EG00110 affected1,724 at risk
Cardiac failure congestive	Cardiac disorders	18.1	Systematic Assessment	EG0005 affected1,752 at risk EG0018 affected1,724 at risk
Ventricular fibrillation	Cardiac disorders	18.1	Systematic Assessment	EG0005 affected1,752 at risk EG0017 affected1,724 at risk
Ventricular tachycardia	Cardiac disorders	18.1	Systematic Assessment	EG0005 affected1,752 at risk EG0017 affected1,724 at risk
Cardiogenic shock	Cardiac disorders	18.1	Systematic Assessment	EG0006 affected1,752 at risk EG0015 affected1,724 at risk
Atrial flutter	Cardiac disorders	18.1	Systematic Assessment	EG0004 affected1,752 at risk EG0014 affected1,724 at risk
Cardiac arrest	Cardiac disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0015 affected1,724 at risk
Atrioventricular block complete	Cardiac disorders	18.1	Systematic Assessment	EG0004 affected1,752 at risk EG0013 affected1,724 at risk
Sinus node dysfunction	Cardiac disorders	18.1	Systematic Assessment	EG0004 affected1,752 at risk EG0013 affected1,724 at risk
Pericardial effusion	Cardiac disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0013 affected1,724 at risk
Coronary artery perforation	Cardiac disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0012 affected1,724 at risk
Pericarditis	Cardiac disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0011 affected1,724 at risk
Arteriospasm coronary	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0012 affected1,724 at risk
Bradycardia	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0013 affected1,724 at risk
Cardiac tamponade	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0012 affected1,724 at risk
Coronary artery disease	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0013 affected1,724 at risk
Coronary artery dissection	Cardiac disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0010 affected1,724 at risk
Myocardial ischaemia	Cardiac disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0010 affected1,724 at risk
Palpitations	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Torsade de pointes	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Ventricular extrasystoles	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Acute coronary syndrome	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Aortic valve disease	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Aortic valve incompetence	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Arrhythmia supraventricular	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Atrioventricular block	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Atrioventricular block second degree	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Bradyarrhythmia	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Cardiac failure acute	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Cardiac ventricular thrombosis	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Coronary artery thrombosis	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Dressler's syndrome	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Hypertensive heart disease	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Left ventricular failure	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Mitral valve incompetence	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Myocardial infarction	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Myocardial rupture	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Myocarditis	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Pericarditis lupus	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Postinfarction angina	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Prinzmetal angina	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Supraventricular tachycardia	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Ventricular dyssynchrony	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Ventricular flutter	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Ventricular tachyarrhythmia	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Pneumonia	Infections and infestations	18.1	Systematic Assessment	EG00012 affected1,752 at risk EG00116 affected1,724 at risk
Sepsis	Infections and infestations	18.1	Systematic Assessment	EG0004 affected1,752 at risk EG0014 affected1,724 at risk
Urinary tract infection	Infections and infestations	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0015 affected1,724 at risk
Cystitis	Infections and infestations	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0013 affected1,724 at risk
Gastroenteritis	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0014 affected1,724 at risk
Urosepsis	Infections and infestations	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0013 affected1,724 at risk
Bronchitis	Infections and infestations	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0011 affected1,724 at risk
Lower respiratory tract infection	Infections and infestations	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0011 affected1,724 at risk
Septic shock	Infections and infestations	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0012 affected1,724 at risk
Cellulitis	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0013 affected1,724 at risk
Gangrene	Infections and infestations	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0010 affected1,724 at risk
Influenza	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0012 affected1,724 at risk
Post procedural cellulitis	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0012 affected1,724 at risk
Infection	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Post procedural infection	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Upper respiratory tract infection	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Acute hepatitis B	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
American trypanosomiasis	Cardiac disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Bacteraemia	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Campylobacter gastroenteritis	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Cholecystitis infective	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Clostridium difficile infection	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Diverticulitis	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Ear infection	Cardiac disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Endocarditis	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Enterococcal infection	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Erysipelas	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Escherichia sepsis	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Gastroenteritis norovirus	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Graft infection	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hepatitis B	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hepatobiliary infection	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Infectious colitis	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Infectious pleural effusion	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Intervertebral discitis	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Klebsiella bacteraemia	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Mediastinitis	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Osteomyelitis	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Peritonitis	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Post procedural pneumonia	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Postoperative wound infection	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Pseudomembranous colitis	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Pulmonary sepsis	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Puncture site infection	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Respiratory tract infection	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Soft tissue infection	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Staphylococcal infection	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Staphylococcal sepsis	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Subcutaneous abscess	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Tracheobronchitis	Infections and infestations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Urinary tract infection bacterial	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Viral infection	Infections and infestations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0016 affected1,724 at risk
Gastritis	Gastrointestinal disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0013 affected1,724 at risk
Colitis	Gastrointestinal disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0012 affected1,724 at risk
Diarrhoea	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0012 affected1,724 at risk
Diverticulum	Gastrointestinal disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0013 affected1,724 at risk
Haematemesis	Gastrointestinal disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0010 affected1,724 at risk
Pancreatitis acute	Gastrointestinal disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Rectal haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Vomiting	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0012 affected1,724 at risk
Abdominal pain	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Abdominal pain upper	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Duodenal ulcer	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Duodenitis	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Erosive oesophagitis	Gastrointestinal disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0010 affected1,724 at risk
Gastritis erosive	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Intestinal haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Pancreatitis	Gastrointestinal disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0010 affected1,724 at risk
Abdominal mass	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Colitis ischaemic	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Crohn's disease	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Duodenal perforation	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Dysphagia	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Enterocolitis	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Faecaloma	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Food poisoning	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Gastrointestinal disorder	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Gastrointestinal pain	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Gastrointestinal ulcer	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Haemorrhoids	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Intestinal ulcer	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Large intestinal ulcer haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Large intestine polyp	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Nausea	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Peptic ulcer	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Proctitis ulcerative	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Rectal polyp	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Small intestinal obstruction	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Ulcerative gastritis	Gastrointestinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Volvulus	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0006 affected1,752 at risk EG0019 affected1,724 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0004 affected1,752 at risk EG0017 affected1,724 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0014 affected1,724 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0014 affected1,724 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0013 affected1,724 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0012 affected1,724 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Pharyngeal haematoma	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Tracheomalacia	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Non-cardiac chest pain	General disorders	18.1	Systematic Assessment	EG00019 affected1,752 at risk EG00115 affected1,724 at risk
Chest pain	General disorders	18.1	Systematic Assessment	EG0005 affected1,752 at risk EG0012 affected1,724 at risk
Death	General disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0013 affected1,724 at risk
Multi-organ failure	General disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0010 affected1,724 at risk
Chest discomfort	General disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0010 affected1,724 at risk
Oedema peripheral	General disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Pyrexia	General disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Vascular stent restenosis	General disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Asthenia	General disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Catheter site haematoma	General disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Catheter site haemorrhage	General disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Discomfort	General disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Drug intolerance	Gastrointestinal disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Medical device complication	General disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Systemic inflammatory response syndrome	General disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0017 affected1,724 at risk
Post procedural complication	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0012 affected1,724 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0013 affected1,724 at risk
Femur fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0011 affected1,724 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0013 affected1,724 at risk
Fall	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0010 affected1,724 at risk
Postoperative renal failure	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Rib fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Animal bite	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Ankle fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Contrast media reaction	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Contusion	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Coronary vascular graft occlusion	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Facial bones fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Failure to anastomose	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Fibula fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Graft loss	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Head injury	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hepatic rupture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Humerus fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Injury	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Overdose	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Patella fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Postimplantation syndrome	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Splenic rupture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Subdural haematoma	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Upper limb fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Wrist fracture	Injury, poisoning and procedural complications	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Acute kidney injury	Renal and urinary disorders	18.1	Systematic Assessment	EG0009 affected1,752 at risk EG00113 affected1,724 at risk
Chronic kidney disease	Renal and urinary disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0016 affected1,724 at risk
Renal failure	Renal and urinary disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0014 affected1,724 at risk
Haematuria	Renal and urinary disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0012 affected1,724 at risk
Calculus ureteric	Renal and urinary disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Nephrolithiasis	Renal and urinary disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Renal impairment	Renal and urinary disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Urogenital haemorrhage	Renal and urinary disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Bladder tamponade	Renal and urinary disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Cystitis haemorrhagic	Renal and urinary disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Haemorrhage urinary tract	Renal and urinary disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Renal haematoma	Renal and urinary disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Urinary retention	Renal and urinary disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hypotension	Vascular disorders	18.1	Systematic Assessment	EG0005 affected1,752 at risk EG0014 affected1,724 at risk
Hypertension	Vascular disorders	18.1	Systematic Assessment	EG0004 affected1,752 at risk EG0012 affected1,724 at risk
Peripheral ischaemia	Vascular disorders	18.1	Systematic Assessment	EG0006 affected1,752 at risk EG0010 affected1,724 at risk
Haematoma	Vascular disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0014 affected1,724 at risk
Peripheral arterial occlusive disease	Vascular disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0011 affected1,724 at risk
Hypertensive crisis	Vascular disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0012 affected1,724 at risk
Circulatory collapse	Vascular disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0010 affected1,724 at risk
Deep vein thrombosis	Vascular disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Orthostatic hypotension	Vascular disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Air embolism	Vascular disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Aortic aneurysm	Vascular disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Aortic dissection	Vascular disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Arterial haemorrhage	Vascular disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Arteriosclerosis	Vascular disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Artery dissection	Vascular disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Extremity necrosis	Vascular disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Ischaemia	Vascular disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Malignant hypertension	Vascular disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Shock haemorrhagic	Vascular disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Thrombophlebitis	Vascular disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Troponin increased	Investigations	18.1	Systematic Assessment	EG00011 affected1,752 at risk EG0019 affected1,724 at risk
Laboratory test abnormal	Investigations	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0011 affected1,724 at risk
Troponin I increased	Investigations	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0012 affected1,724 at risk
Alanine aminotransferase increased	Investigations	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Troponin T increased	Investigations	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Hepatic enzyme increased	Investigations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Liver function test abnormal	Investigations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Myocardial necrosis marker increased	Investigations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Transaminases increased	Investigations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Blood creatinine increased	Investigations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Electrocardiogram QT prolonged	Investigations	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Electrocardiogram change	Investigations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Haemoglobin abnormal	Investigations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
International normalised ratio increased	Investigations	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0004 affected1,752 at risk EG00114 affected1,724 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Back pain	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Myalgia	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0010 affected1,724 at risk
Back disorder	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Myopathy	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Neck pain	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Syncope	Nervous system disorders	18.1	Systematic Assessment	EG0005 affected1,752 at risk EG0014 affected1,724 at risk
Carotid artery stenosis	Nervous system disorders	18.1	Systematic Assessment	EG0004 affected1,752 at risk EG0010 affected1,724 at risk
Dizziness	Nervous system disorders	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0011 affected1,724 at risk
Paraesthesia	Nervous system disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Encephalopathy	Nervous system disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0010 affected1,724 at risk
Epilepsy	Nervous system disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Headache	Nervous system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Presyncope	Nervous system disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Somnolence	Nervous system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Transient ischaemic attack	Nervous system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Brain stem haemorrhage	Nervous system disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Carotid artery disease	Nervous system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Cerebral ischaemia	Nervous system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Cerebrovascular accident	Nervous system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hypertensive encephalopathy	Nervous system disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Hypoaesthesia	Nervous system disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Motor dysfunction	Nervous system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Psychomotor hyperactivity	Nervous system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Quadranopia	Nervous system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Subarachnoid haemorrhage	Nervous system disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Vertebral artery stenosis	Nervous system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0003 affected1,752 at risk EG0012 affected1,724 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Adrenocortical carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Cholangitis	Hepatobiliary disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0012 affected1,724 at risk
Cholecystitis acute	Hepatobiliary disorders	18.1	Systematic Assessment	EG0004 affected1,752 at risk EG0010 affected1,724 at risk
Drug-induced liver injury	Hepatobiliary disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0013 affected1,724 at risk
Cholelithiasis	Hepatobiliary disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0012 affected1,724 at risk
Hepatic function abnormal	Hepatobiliary disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Cholecystitis	Hepatobiliary disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Cholecystitis chronic	Hepatobiliary disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hepatic failure	Hepatobiliary disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Hepatic ischaemia	Hepatobiliary disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hepatic necrosis	Hepatobiliary disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Hepatotoxicity	Hepatobiliary disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Liver disorder	Hepatobiliary disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hypoglycaemia	Metabolism and nutrition disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Hyperglycaemia	Metabolism and nutrition disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Hypokalaemia	Metabolism and nutrition disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0010 affected1,724 at risk
Dehydration	Metabolism and nutrition disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Diabetes mellitus	Metabolism and nutrition disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Gout	Metabolism and nutrition disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hyponatraemia	Metabolism and nutrition disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Metabolic acidosis	Metabolism and nutrition disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Anaemia	Blood and lymphatic system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0015 affected1,724 at risk
Thrombocytopenia	Blood and lymphatic system disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0011 affected1,724 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Coagulopathy	Blood and lymphatic system disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Neutropenia	Blood and lymphatic system disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Acute psychosis	Psychiatric disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Anxiety disorder due to a general medical condition	Psychiatric disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Delirium	Psychiatric disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Depression	Psychiatric disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Hallucination	Psychiatric disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Mental disorder	Psychiatric disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Mental disorder due to a general medical condition	Psychiatric disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Suicide attempt	Psychiatric disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Blindness	Eye disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Diplopia	Eye disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Eye haemorrhage	Eye disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Optic ischaemic neuropathy	Eye disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Retinal artery occlusion	Eye disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Retinal detachment	Eye disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Vertigo	Ear and labyrinth disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0013 affected1,724 at risk
Vestibular disorder	Ear and labyrinth disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Angioedema	Skin and subcutaneous tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Drug eruption	Skin and subcutaneous tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Rash generalised	Skin and subcutaneous tissue disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0010 affected1,724 at risk
Prostatism	Reproductive system and breast disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Prostatitis	Reproductive system and breast disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk
Drug hypersensitivity	Immune system disorders	18.1	Systematic Assessment	EG0002 affected1,752 at risk EG0011 affected1,724 at risk
Gastrointestinal arteriovenous malformation	Congenital, familial and genetic disorders	18.1	Systematic Assessment	EG0000 affected1,752 at risk EG0011 affected1,724 at risk
Primary hyperaldosteronism	Endocrine disorders	18.1	Systematic Assessment	EG0001 affected1,752 at risk EG0010 affected1,724 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypertension	Vascular disorders	18.1	Systematic Assessment	EG00049 affected1,752 at risk EG00133 affected1,724 at risk
Hypotension	Vascular disorders	18.1	Systematic Assessment	EG00029 affected1,752 at risk EG00136 affected1,724 at risk
Troponin increased	Investigations	18.1	Systematic Assessment	EG00039 affected1,752 at risk EG00123 affected1,724 at risk
Angina pectoris	Cardiac disorders	18.1	Systematic Assessment	EG00032 affected1,752 at risk EG00140 affected1,724 at risk
Atrial fibrillation	Cardiac disorders	18.1	Systematic Assessment	EG00065 affected1,752 at risk EG00172 affected1,724 at risk
Cough	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG00038 affected1,752 at risk EG00147 affected1,724 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	18.1	Systematic Assessment	EG00061 affected1,752 at risk EG00148 affected1,724 at risk
Anemia	Blood and lymphatic system disorders	18.1	Systematic Assessment	EG00035 affected1,752 at risk EG00139 affected1,724 at risk
Dizziness	Nervous system disorders	18.1	Systematic Assessment	EG00037 affected1,752 at risk EG00139 affected1,724 at risk
Non-cardiac chest pain	General disorders	18.1	Systematic Assessment	EG00041 affected1,752 at risk EG00144 affected1,724 at risk
Diarrhoea	Gastrointestinal disorders	18.1	Systematic Assessment	EG00041 affected1,752 at risk EG00149 affected1,724 at risk

ID	Term
D054058	Acute Coronary Syndrome
D009203	Myocardial Infarction
D002318	Cardiovascular Diseases
D000072658	Non-ST Elevated Myocardial Infarction
D000072657	ST Elevation Myocardial Infarction

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis

ID	Term
C543534	6-(5-((cyclopropylamino)carbonyl)-3-fluoro-2-methylphenyl)-N-(2,2-dimethylprpyl)-3-pyridinecarboxamide
D059039	Standard of Care

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation