Isavuconazole (BAL8557) in the Treatment of Candidemia an... | NCT00413218

NCT00413218

ID	Type	Description	Link
WSA-CS-008	Other Identifier	Basilea Pharmaceutica Ltd
2006-003951-18	EudraCT Number

Status Module

Name	Class
Basilea Pharmaceutica	INDUSTRY

Oversight Module

Description 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
Isavuconazole (ISA)	Experimental	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.	Drug: Isavuconazole
Caspofungin (CAS)/Voriconazole	Active Comparator	Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.	Drug: Caspofungin Drug: Voriconazole

Name	Type	Description	Arm Group Labels	Other Names
Isavuconazole	Drug	Administered by intravenous infusion.	Isavuconazole (ISA)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use	A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.	End of Intravenous Treatment (EOIV) (Days 11-56)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)	A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Astellas Pharma Global Development	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-0006	United States
Somero Research Corporation

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30289478	Derived	Kullberg BJ, Viscoli C, Pappas PG, Vazquez J, Ostrosky-Zeichner L, Rotstein C, Sobel JD, Herbrecht R, Rahav G, Jaruratanasirikul S, Chetchotisakd P, Van Wijngaerden E, De Waele J, Lademacher C, Engelhardt M, Kovanda L, Croos-Dabrera R, Fredericks C, Thompson GR. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive Candida Infections: The ACTIVE Trial. Clin Infect Dis. 2019 May 30;68(12):1981-1989. doi: 10.1093/cid/ciy827.
25902926

Label	URL
Link to results on the Astellas Clinical Study Results website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
BG001	Caspofungin (CAS)/Voriconazole	Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
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

Geometric Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00058.0± 17.54 BG00157.9± 16.88 BG00258.0± 17.20

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00078 BG00193 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000150 BG001144 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG00026 BG00119 BG002

Neutropenic Status: Presence or Absence of Neutropenia

Participants were stratified by baseline neutropenic status (presence vs absence of neutropenia) defined as absolute neutrophil count (ANC) < 0.5 x 10^9/L [< 500/mm^3] for ≥ 10 days.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Presence	BG00025 BG001

Geographical Region

Participants were stratified at randomization by geographical region. The region Western Europe includes countries in Western Europe (Belgium, France, Germany, Italy, Spain and Switzerland), Australia and New Zealand. Other regions include countries Argentina, Brazil, Chile, China, Hungary, India, Israel, Lebanon, Malaysia, Mexico, Philippines, South Africa, Russia, Singapore and Thailand.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
North America	BG00038 BG001

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

Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use

A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.

The ITT population consisted of all randomized participants who received at least one dose of study drug. The mITT population consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. Reporting arms included participants who switched to oral ISA and CAS.

Posted

Number

Percentage of Participants

End of Intravenous Treatment (EOIV) (Days 11-56)

ID	Title	Description
OG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
OG001	Caspofungin (CAS)/Voriconazole	Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.

Units	Counts
Participants	OG000199 OG001201

Title

Denominators

Categories

Title	Measurements
	OG00060.3 OG00171.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The adjusted treatment difference (ISA-CAS) was calculated by a stratified Cochran-Mantel-Haenszel (CMH) method with the strata of geographical region and baseline neutropenic status.					Adjusted Treatment Difference (%)	-10.8			2-Sided	95	-19.9	-1.8			The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.		Non-Inferiority	The lower bound of the 95% CI for the adjusted treatment difference was compared to the protocol prespecified noninferiority margin (NIM) value of -15%. If the lower bound were greater than -15%, isavuconazole would be declared as noninferior to caspofungin.

Secondary

Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)

The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.

Posted

Number

Percentage of Participants

End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)

ID	Title	Description
OG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
OG001	Caspofungin (CAS)/Voriconazole

Secondary

Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2

A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis).

Posted

Number

Percentage of Participants

EOT (Day 56) and FU2 (6 weeks after end of treatment)

ID	Title	Description
OG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.

Secondary

Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)

Posted

Number

Percentage of Participants

EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)

ID	Title	Description
OG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
OG001	Caspofungin (CAS)/Voriconazole	Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.

Secondary

Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)

Posted

Number

Percentage of Participants

EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)

ID	Title	Description
OG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
OG001	Caspofungin (CAS)/Voriconazole	Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.

Secondary

Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator

Success was defined as mycological response (eradication or presumed eradication).

Posted

Number

Percentage of Participants

Day 7 and EOT (Day 56)

ID	Title	Description
OG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
OG001	Caspofungin (CAS)/Voriconazole	Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.

Secondary

Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator

Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms.

Posted

Number

Percentage of Participants

Day 7 and EOT (Day 56)

ID	Title	Description
OG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic participants could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily.
OG001	Caspofungin (CAS)/Voriconazole	Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.

Secondary

All-Cause Mortality (ACM) at Day 14 and Day 56

All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56.

Posted

Number

Percentage of Participants

Day 14 and Day 56

ID	Title	Description
OG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
OG001	Caspofungin (CAS)/Voriconazole	Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.

Secondary

Time to First Confirmed Negative Culture

The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant's last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis

Posted

Median

95% Confidence Interval

Days

Day 1 up to FU1 (2 weeks after EOT (Day 56))

ID	Title	Description
OG000	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
OG001	Caspofungin (CAS)/Voriconazole	Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.

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	Isavuconazole (ISA)	Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily.	55	220	112	220	162	220
EG001	Caspofungin (CAS)/Voriconazole	Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.	55	220	106	220	167	220

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0013 events3 affected220 at risk
Anaemia haemolytic autoimmune	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0012 events2 affected220 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Arrhythmia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Bradycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Cardiac arrest	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0006 events4 affected220 at risk EG0016 events6 affected220 at risk
Cardiac failure	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0012 events2 affected220 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Pericardial effusion	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Torsade de pointes	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0010 events0 affected220 at risk
Sickle cell anaemia with crisis	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Diabetes insipidus	Endocrine disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Vision blurred	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0013 events2 affected220 at risk
Ascites	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0010 events0 affected220 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Melaena	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0012 events2 affected220 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0012 events1 affected220 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0013 events3 affected220 at risk
Chest discomfort	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Chills	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Death	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Drug withdrawal syndrome	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
General physical health deterioration	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Impaired healing	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Multi-organ failure	General disorders	MedDRA 12.1	Systematic Assessment	EG0005 events5 affected220 at risk EG0017 events7 affected220 at risk
Necrosis	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0010 events0 affected220 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0012 events2 affected220 at risk
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0002 events1 affected220 at risk EG0010 events0 affected220 at risk
Abdominal abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 events2 affected220 at risk EG0012 events2 affected220 at risk
Abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected220 at risk EG0010 events0 affected220 at risk
Bacterial sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected220 at risk EG0014 events4 affected220 at risk
Candida endophthalmitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Catheter related infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Cellulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Cerebral aspergillosis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Device related infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events1 affected220 at risk EG0010 events0 affected220 at risk
Diverticulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Enterobacter sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Fungal infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Infected skin ulcer	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Klebsiella infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0011 events1 affected220 at risk
Lung abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Mediastinitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Meningitis bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0010 events0 affected220 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0016 events6 affected220 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Postoperative wound infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00016 events16 affected220 at risk EG0019 events9 affected220 at risk
Septic shock	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00019 events19 affected220 at risk EG00112 events11 affected220 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Systemic candida	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Tracheobronchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Urosepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0012 events2 affected220 at risk
Wound abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Brain herniation	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Donor site complication	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events1 affected220 at risk EG0010 events0 affected220 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Blood bilirubin increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Blood creatinine increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
C-reactive protein increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Hepatic enzyme abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Hepatic enzyme increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0012 events2 affected220 at risk
Liver function test abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Oxygen saturation decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected220 at risk EG0010 events0 affected220 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 events1 affected220 at risk EG0010 events0 affected220 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0013 events3 affected220 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Acute myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Hodgkin's disease refractory	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Basilar artery thrombosis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Convulsion	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Hypoglycaemic encephalopathy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Hypoxic encephalopathy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Intracranial haematoma	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Partial seizures	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Somnolence	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Status epilepticus	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Vasogenic cerebral oedema	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Nephrectasia	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Renal failure	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0012 events2 affected220 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG00010 events10 affected220 at risk EG0013 events3 affected220 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0010 events0 affected220 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0011 events1 affected220 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0011 events1 affected220 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected220 at risk EG0012 events2 affected220 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0011 events1 affected220 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected220 at risk EG0012 events2 affected220 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0010 events0 affected220 at risk
Pulmonary necrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 events5 affected220 at risk EG0011 events1 affected220 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00013 events12 affected220 at risk EG0018 events8 affected220 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Arteriosclerosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0011 events1 affected220 at risk
Haematoma	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Haemodynamic instability	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected220 at risk EG0011 events1 affected220 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected220 at risk EG0011 events1 affected220 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected220 at risk EG0010 events0 affected220 at risk
Shock	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0010 events0 affected220 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected220 at risk EG0010 events0 affected220 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG00014 events13 affected220 at risk EG00121 events18 affected220 at risk
Tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG00020 events18 affected220 at risk EG00110 events9 affected220 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00017 events16 affected220 at risk EG00123 events20 affected220 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00034 events32 affected220 at risk EG00131 events24 affected220 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00037 events33 affected220 at risk EG00149 events41 affected220 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00028 events21 affected220 at risk EG00137 events30 affected220 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00044 events33 affected220 at risk EG00149 events37 affected220 at risk
Chills	General disorders	MedDRA 12.1	Systematic Assessment	EG00015 events11 affected220 at risk EG0016 events6 affected220 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG00017 events15 affected220 at risk EG00117 events16 affected220 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG00056 events38 affected220 at risk EG00173 events41 affected220 at risk
Bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00012 events11 affected220 at risk EG0019 events9 affected220 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00013 events13 affected220 at risk EG00110 events9 affected220 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0007 events7 affected220 at risk EG00112 events12 affected220 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected220 at risk EG00112 events11 affected220 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0005 events5 affected220 at risk EG00111 events11 affected220 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00019 events18 affected220 at risk EG00121 events18 affected220 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00049 events41 affected220 at risk EG00150 events44 affected220 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00022 events18 affected220 at risk EG00131 events29 affected220 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00012 events12 affected220 at risk EG00116 events14 affected220 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00015 events15 affected220 at risk EG00111 events9 affected220 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG00015 events13 affected220 at risk EG0016 events6 affected220 at risk
Agitation	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0005 events5 affected220 at risk EG00115 events13 affected220 at risk
Anxiety	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG00011 events11 affected220 at risk EG0018 events7 affected220 at risk
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG00013 events12 affected220 at risk EG00110 events10 affected220 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00011 events10 affected220 at risk EG00114 events13 affected220 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00018 events15 affected220 at risk EG00114 events14 affected220 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00011 events11 affected220 at risk EG00112 events12 affected220 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG00015 events14 affected220 at risk EG00119 events10 affected220 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0009 events9 affected220 at risk EG00113 events12 affected220 at risk
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG00030 events22 affected220 at risk EG00129 events27 affected220 at risk
Phlebitis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG00014 events14 affected220 at risk EG00120 events15 affected220 at risk

Certain Agreements

ID	Term
D058365	Candidiasis, Invasive
D058387	Candidemia
D009181	Mycoses

ID	Term
D002177	Candidiasis
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000072742	Invasive Fungal Infections
D016469	Fungemia
D018805	Sepsis
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D055666	Lipopeptides
D008055	Lipids
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D054714	Echinocandins
D010456	Peptides, Cyclic
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
C508735	isavuconazole
D000077336	Caspofungin
D065819	Voriconazole