A Study of Apixaban in Patients With Atrial Fibrillation,... | NCT02415400

NCT02415400

ID	Type	Description	Link
2014-002004-24	EudraCT Number

Status Module

Name	Class
Pfizer	INDUSTRY
Duke Clinical Research Institute	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Apixaban	Active Comparator	5 mg or 2.5 mg Apixaban tablets orally twice per day	Drug: Apixaban
Vitamin K Antagonist	Active Comparator	VKA tablets orally once daily	Drug: vitamin K antagonist
Acetylsalicylic acid film coated tablet	Placebo Comparator	81 mg Acetylsalicylic acid film coated tablet orally once daily	Drug: Acetylsalicylic acid
Placebo matching Acetylsalicylic acid film coated tablet	Placebo Comparator	Placebo matching Acetylsalicylic acid film coated tablet once daily	Other: Acetylsalicylic acid placebo

Name	Type	Description	Arm Group Labels	Other Names
Apixaban	Drug		Apixaban	BMS-562247
vitamin K antagonist

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period	Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period	Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo. N is the number of participants with aspirin or placebo. n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months

Secondary Outcomes

Measure	Description	Time Frame
Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA	Time to first occurrence during the time the participants were treated with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Eligibility Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Associates of the Southeast, LLC		Birmingham	Alabama	35243	United States
University of Alabama at Birmingham

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40117694	Derived	Fudim M, Lopes RD, Wojdyla DM, Mehran R, Khan MS, Granger CB, Goodman SG, Aronson R, Windecker S, Alexander JH. Apixaban Dose in Patients With Atrial Fibrillation and Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention: Insights From AUGUSTUS. JACC Adv. 2025 Apr;4(4):101665. doi: 10.1016/j.jacadv.2025.101665. Epub 2025 Mar 20.
39918467

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Apixaban With Acetylsalicylic Acid Film Coated Tablet	5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
FG001	Apixaban With Placebo Matching Acetylsalicylic Acid

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 21, 2018	Nov 7, 2019

Arm/Group Information

ID	Title	Description
BG000	Apixaban With Acetylsalicylic Acid Film Coated Tablet	5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
BG001	Apixaban With Placebo Matching Acetylsalicylic Acid	5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
BG002	Vitamin K Antagonist (VKA) With Acetylsalicylic	VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
BG003	VKA With Placebo Matching Acetylsalicylic Acid	VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
BG004	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
	BG00070.2± 9.12 BG00169.3± 9.32 BG00270.0± 9.09 BG003

Age, Customized

Number

Participants

Title

Denominators

Categories

< 65 years old

Title	Measurements
	BG000308 BG001333 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000357 BG001313 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG00110 BG002

Race/Ethnicity, Customized

Table is for category of Race.

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG0001039 BG0011058 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

The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period

Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA.

N is the number of participants treated with Apixaban or VKA.

n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.

Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Participants treated with Apixaban or VKA.

Assessment is only for the Apixaban and VKA interventions.

Posted

Number

Percentage per year

Approximately 6 months

ID	Title	Description
OG000	Apixaban	5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
OG001	Vitamin K Antagonist	VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy

Units	Counts
Participants	OG0002290 OG0012259

Title

Denominators

Categories

Title	Measurements
	OG00024.66 OG00135.79

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	Separate hierarchical testing was performed for apixaban vs VKA: 1) Non-inferiority for the primary endpoint.	1-sided p-value for NI test		<0.0001														Non-Inferiority	Non-Inferiority (NI) margin = 1.2
OG000 OG001	Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint

Primary

The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period

Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo.

N is the number of participants with aspirin or placebo.

n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment.

Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Participants treated with aspirin or placebo.

Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions.

Posted

Number

Percentage per year

Approximately 6 months

ID	Title	Description
OG000	Acetylsalicylic Acid Film Coated Tablet	81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
OG001	Placebo Matching Acetylsalicylic Acid Film Coated Tablet	Placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy

Secondary

Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA

Time to first occurrence during the time the participants were treated with Apixaban or VKA.

N is the number of participants treated with Apixaban or VKA.

n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.

Participants treated with Apixaban or VKA.

Assessment is only for the Apixaban or VKA interventions.

Posted

Number

Percentage per year

Approximately 6 months

ID	Title	Description
OG000	Apixaban	5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
OG001	Vitamin K Antagonist	VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy

Units	Counts
Participants

Secondary

The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA

Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA.

N is the number of participants treated with Apixaban or VKA.

n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.

Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Participants randomized to Apixaban or VKA.

Assessment is only for the Apixaban or VKA interventions.

Posted

Number

Percentage per year

Approximately 6 months

ID	Title	Description
OG000	Apixaban	5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
OG001	Vitamin K Antagonist	VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy

Units	Counts

Secondary

The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin

Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo.

N is the number of participants treated with aspirin or placebo.

n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.

Participants randomized to aspirin or placebo.

Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions.

Posted

Number

Percentage per year

Approximately 6 months

ID	Title	Description
OG000	Acetylsalicylic Acid Film Coated Tablet	81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
OG001	Placebo Matching Acetylsalicylic Acid Film Coated Tablet	Placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy

Secondary

The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA

Time to first occurrence during the 6-month treatment period with Apixaban or VKA.

N is the number of participants treated with Apixaban or VKA.

n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment.

Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Participants randomized to Apixaban or VKA.

Assessment is only for the Apixaban or VKA interventions.

Posted

Number

Percentage per year

Approximately 6 months

ID	Title	Description
OG000	Apixaban	5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
OG001	Vitamin K Antagonist	VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy

Units	Counts

Secondary

The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin

Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo.

N is the number of participants treated with aspirin or placebo.

n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period.

Participants randomized to aspirin or placebo.

Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions.

Posted

Number

Percentage per year

Approximately 6 months

ID	Title	Description
OG000	Acetylsalicylic Acid Film Coated Tablet	81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
OG001	Placebo Matching Acetylsalicylic Acid Film Coated Tablet	Placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy

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	Apixaban With Acetylsalicylic Acid Film Coated Tablet	5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy	42	1,145	53	1,145	35	1,145
EG001	Apixaban With Placebo Matching Acetylsalicylic Acid	5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy	46	1,143	50	1,143	21	1,143
EG002	Vitamin K Antagonist (VKA) With Acetylsalicylic Acid	VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy	38	1,123	52	1,123	33	1,123
EG003	VKA With Placebo Matching Acetylsalicylic Acid	VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy	42	1,127	55	1,126	18	1,126
EG004	APIXABAN ONLY	Only Apixaban intervention received: 5 mg or 2.5 mg Apixaban tablets orally twice per day	0	2	0	2	0	2
EG005	VKA ONLY	Only VKA intervention received: VKA tablets orally once daily	3	10	3	10	1	10
EG006	ACETYLSALICLIC ACID ONLY	Only acetylsalicylic acid intervention received: 81 mg Acetylsalicylic acid film coated tablet orally once daily	0	9	0	9	3	9
EG007	PLACEBO MATCHING ACETYLSALICLIC ACID ONLY	Only placebo matching acetylsalicylic acid intervention received: placebo matching Acetylsalicylic acid film coated tablet orally once daily	0	10	0	10	0	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG0030 affected1,126 at risk EG0040 affected2 at risk EG0050 affected10 at risk EG0060 affected9 at risk EG0070 affected10 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,145 at risk EG0011 affected1,143 at risk EG0026 affected1,123 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,145 at risk EG0013 affected1,143 at risk EG0023 affected1,123 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0019 affected1,143 at risk EG0025 affected1,123 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0012 affected1,143 at risk EG0020 affected1,123 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0011 affected1,143 at risk EG0021 affected1,123 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0021 affected1,123 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,145 at risk EG0012 affected1,143 at risk EG0022 affected1,123 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Cardiovascular disorder	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0021 affected1,123 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,145 at risk EG0015 affected1,143 at risk EG0025 affected1,123 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0011 affected1,143 at risk EG0022 affected1,123 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Cardiac death	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Death	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Multimorbidity	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Sudden cardiac death	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,145 at risk EG0012 affected1,143 at risk EG0021 affected1,123 at risk EG003
Sudden death	General disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected1,145 at risk EG0013 affected1,143 at risk EG0022 affected1,123 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Liver injury	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Meningoencephalitis bacterial	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0011 affected1,143 at risk EG0022 affected1,123 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0012 affected1,143 at risk EG0021 affected1,123 at risk EG003
Septic shock	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected1,145 at risk EG0011 affected1,143 at risk EG0021 affected1,123 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0011 affected1,143 at risk EG0021 affected1,123 at risk EG003
Brain herniation	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 affected1,145 at risk EG0010 affected1,143 at risk EG0025 affected1,123 at risk EG003
International normalised ratio increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Renal cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Brain injury	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0023 affected1,123 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Status epilepticus	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0012 affected1,143 at risk EG0020 affected1,123 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Shock	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0011 affected1,143 at risk EG0020 affected1,123 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG00016 affected1,145 at risk EG0013 affected1,143 at risk EG00210 affected1,123 at risk EG0036 affected1,126 at risk EG0040 affected2 at risk EG0050 affected10 at risk EG0061 affected9 at risk EG0070 affected10 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0008 affected1,145 at risk EG0018 affected1,143 at risk EG0029 affected1,123 at risk EG003
Puncture site reaction	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0020 affected1,123 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0005 affected1,145 at risk EG0011 affected1,143 at risk EG0022 affected1,123 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected1,145 at risk EG0010 affected1,143 at risk EG0021 affected1,123 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0009 affected1,145 at risk EG0013 affected1,143 at risk EG0025 affected1,123 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,145 at risk EG0013 affected1,143 at risk EG0025 affected1,123 at risk EG003
Haematoma	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,145 at risk EG0013 affected1,143 at risk EG0026 affected1,123 at risk EG003

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals