Evaluating Ventricular Arrhythmia in Subjects With Implan... | NCT02104583

ID	Type	Description	Link
2013-004430-15	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eleclazine 3 mg	Experimental	Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 20 months.	Drug: Eleclazine
Eleclazine 6 mg	Experimental	Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 6 mg daily as maintenance for up to approximately 20 months.	Drug: Eleclazine
Placebo	Placebo Comparator	Participants will receive a single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.	Drug: Placebo to match eleclazine

Name	Type	Description	Arm Group Labels	Other Names
Eleclazine	Drug	Eleclazine tablets administered orally	Eleclazine 3 mg Eleclazine 6 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24		Randomization up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study		Randomization up to 22 months
Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring

Eligibility Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Associates of Mesa		Mesa	Arizona	85206	United States
Long Beach Memorial Hospital

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
FG001	Cohort 1 Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
BG001	Cohort 1 Placebo	Participants received single loading dose of placebo to match eleclazine tablets On Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months
BG002	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
BG003	Cohort 2 Eleclazine 6 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
BG004	Cohort 2 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
BG005	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

Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00048 ParticipantsBG00146 ParticipantsBG00270 ParticipantsBG003

Sex: Female, Male

Participants in the Safety Analysis Set were analyzed.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00048 ParticipantsBG00146 ParticipantsBG002

Race/Ethnicity, Customized

Participants in the Safety Analysis Set were analyzed.

Count of Participants

Participants

Title	Denominators	Categories
Race	ParticipantsBG00048 ParticipantsBG00146 ParticipantsBG002

Race/Ethnicity, Customized

Participants in the Safety Analysis Set were analyzed.

Count of Participants

Participants

Title	Denominators	Categories
Ethnicity	ParticipantsBG00048 ParticipantsBG00146 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
United States	ParticipantsBG00048 ParticipantsBG00146 ParticipantsBG002

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

Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24

Participants in the Full Analysis Set-ICD [all participants who were randomized into the study and received at least 1 dose of study medication, restricted to participants who had at least 1 postbaseline ICD/cardiac resynchronization therapy-defibrillator (CRT-D) interrogation] with available data were analyzed.

Posted

Mean

Standard Deviation

events

Randomization up to 24 weeks

ID	Title	Description
OG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
OG001	Cohort 1 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
OG002	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
OG003	Cohort 2 Eleclazine 6 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.
OG004	Cohort 2 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.
OG005	Cohorts 1 and 2, Eleclazine 3 mg	All randomized participants across cohorts 1 and 2 who received single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 22 months.
OG006	Cohorts 1 and 2, Placebo	All randomized participants across cohorts 1 and 2 who received single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.

Units	Counts
Participants	OG00048 OG00146 OG00269 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003.3± 6.99 OG0011.9± 3.79 OG0022.6± 6.8 OG003

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
OG005 OG006	The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region [US or rest of world (ROW)].	generalized linear model		0.152		Eleclazine : Placebo Incident Rate Ratio	1.52			2-Sided	95	0.86	2.71					Superiority

Secondary

Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study

Participants in the Full Analysis Set-ICD with available data were analyzed.

Posted

Mean

Standard Deviation

events

Randomization up to 22 months

ID	Title	Description
OG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
OG001	Cohort 1 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
OG002	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
OG003	Cohort 2 Eleclazine 6 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.

Secondary

Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring

PVC count per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in PVC from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.

Participants in the Full Analysis Set (all participants who were randomized into the study and received at least 1 dose of study medication) with available data were analyzed.

Posted

Mean

Standard Deviation

episodes/48 hours

Baseline to Week 12

ID	Title	Description
OG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
OG001	Cohort 1 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
OG002	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.

Secondary

Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring

The count of nsVTs per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in nsVT from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

episodes/48 hours

Baseline to Week 12

ID	Title	Description
OG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
OG001	Cohort 1 Placebo	Participants received single loading dose of placebo to match eleclazine tabletson Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
OG002	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.

Secondary

Overall Occurrence (Total Number) of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) (Treated or Untreated) Through Week 24 and End of Study

Participants in the Full Analysis Set-ICD with available data were analyzed.

Posted

Mean

Standard Deviation

events

Randomization up to Week 24; Randomization up to end of study (up to 22 months)

ID	Title	Description
OG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
OG001	Cohort 1 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
OG002	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
OG003	Cohort 2 Eleclazine 6 mg

Secondary

Overall Occurrence (Total Number) of Electrical Storm Through Week 24 and End of Study

An electrical storm was defined as ≥ 3 separate episodes of ventricular arrhythmia within a 24-hour period terminated by ICD.

Participants in the Full Analysis Set-ICD with available data were analyzed.

Posted

Mean

Standard Deviation

events

Randomization up to Week 24; Randomization up to end of study (up to 22 months)

ID	Title	Description
OG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
OG001	Cohort 1 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
OG002	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
OG003

Secondary

Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study

Participants in the Full Analysis Set-ICD with available data were analyzed.

Posted

Mean

Standard Deviation

events

Randomization up to Week 24; Randomization up to end of study (up to 22 months)

ID	Title	Description
OG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
OG001	Cohort 1 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
OG002	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
OG003	Cohort 2 Eleclazine 6 mg

Secondary

Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF)

LVEF is a measure of how much blood is pumped out of the left ventricle of the heart. Change from baseline was calculated as the value at Week 12 or 24 minus the value at Baseline.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

percentage of blood

Baseline to Week 12; Baseline to Week 24

ID	Title	Description
OG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.
OG001	Cohort 1 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.
OG002	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.

Secondary

Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death

CV deaths were determined through the adjudication by an external independent clinical event committee (CEC). The deaths that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the beginning of the earliest appropriate ICD intervention through the last day on study or, in absence of appropriate ICD interventions, to a CV death was derived as (first event date - first dose date + 1). The participants without appropriate ICD interventions or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of an appropriate ICD interventions or CV death was analyzed using Kaplan-Meier (KM) estimates.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Median

95% Confidence Interval

days

From first dose of study drug up to 22 months

ID	Title	Description
OG000	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
OG001	Cohort 2 Eleclazine 6 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.

Secondary

Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death

CV hospitalizations, CV ER visits, and CV deaths were determined through the adjudication by the CEC. The events that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the first CV hospitalization or CV ER visit through the last day on study or, in absence of CV hospitalizations or CV ER visits, to a CV death were derived as (first event date - first dose date + 1). The participants without CV hospitalizations, CV ER visits, or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of CV hospitalization, ER visit, or CV death was analyzed using KM estimates.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Median

95% Confidence Interval

days

From first dose of study drug up to 22 months

ID	Title	Description
OG000	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.
OG001	Cohort 2 Eleclazine 6 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 22 months.	27	48	32	48
EG001	Cohort 1 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablet once daily for up to approximately 20 months.	25	46	26	46
EG002	Cohort 2 Eleclazine 3 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 3 mg tablet once daily as maintenance for up to approximately 14 months.	28	70	42	70
EG003	Cohort 2 Eleclazine 6 mg	Participants received single loading dose of eleclazine 30 mg (3 x 10 mg tablets) on Day 1, followed by eleclazine 6 mg (2 x 3 mg tablets) once daily as maintenance for up to approximately 14 months.	26	73	34	73
EG004	Cohort 2 Placebo	Participants received single loading dose of placebo to match eleclazine tablets on Day 1, followed by placebo to match eleclazine tablets once daily for up to approximately 14 months.	26	75	33	75

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG0030 affected73 at risk EG0040 affected75 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0021 affected70 at risk EG003
Acute right ventricular failure	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Anginal equivalent	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0011 affected46 at risk EG0024 affected70 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0022 affected70 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0004 affected48 at risk EG0011 affected46 at risk EG0021 affected70 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Chronic left ventricular failure	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Cor pulmonale	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0022 affected70 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Palpitations	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0012 affected46 at risk EG0025 affected70 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0013 affected46 at risk EG0020 affected70 at risk EG003
Ventricular flutter	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 19	Systematic Assessment	EG00011 affected48 at risk EG00110 affected46 at risk EG0027 affected70 at risk EG003
Retinal detachment	Eye disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Coeliac artery compression syndrome	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Chest discomfort	General disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Chest pain	General disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Phantom shocks	General disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Hydrocholecystis	Hepatobiliary disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Abscess limb	Infections and infestations	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Bronchitis	Infections and infestations	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Cellulitis	Infections and infestations	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Endocarditis pseudomonal	Infections and infestations	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0021 affected70 at risk EG003
Septic shock	Infections and infestations	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Tooth infection	Infections and infestations	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Viral infection	Infections and infestations	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Chemical burn of skin	Injury, poisoning and procedural complications	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Anticoagulation drug level below therapeutic	Investigations	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Brain injury	Nervous system disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Parosmia	Nervous system disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Presyncope	Nervous system disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Syncope	Nervous system disorders	MedDRA 19	Systematic Assessment	EG0002 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Device dislocation	Product Issues	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Device inappropriate shock delivery	Product Issues	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Device malfunction	Product Issues	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0011 affected46 at risk EG0021 affected70 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Hypotension	Vascular disorders	MedDRA 19	Systematic Assessment	EG0002 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Phlebitis	Vascular disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0004 affected48 at risk EG0012 affected46 at risk EG0024 affected70 at risk EG0032 affected73 at risk EG0043 affected75 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 19	Systematic Assessment	EG0008 affected48 at risk EG0012 affected46 at risk EG0028 affected70 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0004 affected48 at risk EG0011 affected46 at risk EG0022 affected70 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0012 affected46 at risk EG0025 affected70 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19	Systematic Assessment	EG0002 affected48 at risk EG0010 affected46 at risk EG0024 affected70 at risk EG003
Asthenia	General disorders	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0011 affected46 at risk EG0021 affected70 at risk EG003
Chest discomfort	General disorders	MedDRA 19	Systematic Assessment	EG0004 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Chest pain	General disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0013 affected46 at risk EG0023 affected70 at risk EG003
Fatigue	General disorders	MedDRA 19	Systematic Assessment	EG0005 affected48 at risk EG0017 affected46 at risk EG0026 affected70 at risk EG003
Oedema peripheral	General disorders	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0013 affected46 at risk EG0022 affected70 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19	Systematic Assessment	EG0004 affected48 at risk EG0011 affected46 at risk EG0021 affected70 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0014 affected46 at risk EG0021 affected70 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0010 affected46 at risk EG0022 affected70 at risk EG003
Blood magnesium decreased	Investigations	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0010 affected46 at risk EG0020 affected70 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0013 affected46 at risk EG0020 affected70 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0012 affected46 at risk EG0022 affected70 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0011 affected46 at risk EG0020 affected70 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0010 affected46 at risk EG0021 affected70 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19	Systematic Assessment	EG0005 affected48 at risk EG0014 affected46 at risk EG0026 affected70 at risk EG003
Headache	Nervous system disorders	MedDRA 19	Systematic Assessment	EG0004 affected48 at risk EG0012 affected46 at risk EG0023 affected70 at risk EG003
Syncope	Nervous system disorders	MedDRA 19	Systematic Assessment	EG0002 affected48 at risk EG0014 affected46 at risk EG0022 affected70 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 19	Systematic Assessment	EG0001 affected48 at risk EG0013 affected46 at risk EG0021 affected70 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 19	Systematic Assessment	EG0000 affected48 at risk EG0015 affected46 at risk EG0021 affected70 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19	Systematic Assessment	EG0005 affected48 at risk EG0014 affected46 at risk EG0027 affected70 at risk EG003
Hypotension	Vascular disorders	MedDRA 19	Systematic Assessment	EG0003 affected48 at risk EG0012 affected46 at risk EG0024 affected70 at risk EG003

ID	Term
D013610	Tachycardia
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D017180	Tachycardia, Ventricular
D014693	Ventricular Fibrillation
D012769	Shock