A Multiple-Dose Study To Evaluate The Pharmacokinetics An... | NCT00556998

Label	Type	Description	Intervention Names
1	Experimental		Drug: Voriconazole

Name	Type	Description	Arm Group Labels	Other Names
Voriconazole	Drug	Voriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.

Measure	Description	Time Frame
Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration	AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.	Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration		Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
Time to Reach Cmax (Tmax) Following IV Administration		Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
AUC12,ss Following Oral Administration	AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.	Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
Cmax,ss Following Oral Administration		Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
Tmax Following Oral Administration		Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose

Measure	Description	Time Frame
AUC12 Following IV Loading Dose	AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.	Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
Tmax Following an IV Loading Dose

Measure	Description	Time Frame
Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Loading Dose.	Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Chicago	Illinois	60637	United States
Pfizer Investigational Site

ID	Title	Description
FG000	All Treatments	Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

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

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration

AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.

Intent to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Geometric Mean

Standard Deviation

μg*h/mL

Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).

Units	Counts
Participants	OG00023

Title

Denominators

Categories

Title	Measurements
	OG00022.39± 21.47

Primary

Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Geometric Mean

Standard Deviation

μg/mL

Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).

Units	Counts
Participants	OG000

Primary

Time to Reach Cmax (Tmax) Following IV Administration

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Median

Full Range

hours

Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).

Units	Counts
Participants	OG00023

Primary

AUC12,ss Following Oral Administration

AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Geometric Mean

Standard Deviation

μg*h/mL

Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG000

Primary

Cmax,ss Following Oral Administration

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Geometric Mean

Standard Deviation

μg/mL

Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG00019

Primary

Tmax Following Oral Administration

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Median

Full Range

hours

Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG00019

Secondary

AUC12 Following IV Loading Dose

AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Geometric Mean

Standard Deviation

μg*h/mL

Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.

Units	Counts
Participants	OG000

Secondary

Tmax Following an IV Loading Dose

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Median

Full Range

hours

Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.

Units	Counts
Participants	OG00022

Secondary

Cmax Following an IV Loading Dose

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Geometric Mean

Standard Deviation

μg/mL

Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.

Units	Counts
Participants	OG00022

Secondary

Minimum Observed Plasma Trough Concentration (Cmin)

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data.

Posted

Geometric Mean

Standard Deviation

μg/mL

Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose

ID	Title	Description
OG000	All Treatments	Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2-7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG000

Secondary

AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Geometric Mean

Standard Deviation

μg*h/mL

Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).

Units	Counts
Participants	OG000

Secondary

Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Geometric Mean

Standard Deviation

μg/mL

Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).

Units	Counts
Participants	OG000

Secondary

Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Median

Full Range

μg*h/mL

Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).

Units	Counts
Participants	OG000

Secondary

AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Geometric Mean

Standard Deviation

μg*h/mL

On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG000

Secondary

Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Geometric Mean

Standard Deviation

μg/mL

Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG000

Secondary

Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Posted

Median

Full Range

hours

Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG000

Other Pre-specified

Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Loading Dose.

Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

Not Posted

Geometric Mean

Full Range

mcg*hr/mL

Day 1

Other Pre-specified

Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Steady State

Not Posted

Geometric Mean

Full Range

mcg*hr/mL

Day 7 of IV dosing

Other Pre-specified

Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral Dose All Subjects

Not Posted

Geometric Mean

Full Range

mcg*hr/mL

Day 7 Oral dosing

Other Pre-specified

Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral 300mg

Not Posted

Geometric Mean

Full Range

mcg*hr/mL

Day 7 oral dosing

Other Pre-specified

Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Loading Dose

Not Posted

Geometric Mean

Full Range

mcg/mL

Day 1

Other Pre-specified

Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Steady State

Not Posted

Geometric Mean

Full Range

mcg/mL

Day 7 of Intravenous dosing

Other Pre-specified

Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax Day 7 Oral All Participants

Not Posted

Geometric Mean

Full Range

mcg/mL

Day 7 of oral dosing

Other Pre-specified

Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax 300 mg Oral Dose

Not Posted

Day 7 of oral dosing

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0012 affected22 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0013 affected22 at risk
Tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Colour blindness	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Ear canal erythema	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected22 at risk
Conjunctival irritation	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Conjunctivitis	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Dry eye	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Hypermetropia	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Photophobia	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Strabismus	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Vision blurred	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Visual impairment	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0013 affected22 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Anorectal disorder	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Ascites	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Breath odour	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Chapped lips	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0014 affected22 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected26 at risk EG0015 affected22 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Faecal volume increased	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Flatulence	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0013 affected22 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0013 affected22 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Lip dry	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Lip haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected22 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected26 at risk EG0016 affected22 at risk
Oral pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0011 affected22 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Rectal fissure	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0010 affected22 at risk
Toothache	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected26 at risk EG0015 affected22 at risk
Catheter related complication	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Chills	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Drug withdrawal syndrome	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Face oedema	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Gait disturbance	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Generalised oedema	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Mucosal inflammation	General disorders	MedDRA 12.1	Systematic Assessment	EG00011 affected26 at risk EG0019 affected22 at risk
Oedema	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0014 affected22 at risk
Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0012 affected22 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG00013 affected26 at risk EG0015 affected22 at risk
Suprapubic pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected26 at risk EG0013 affected22 at risk
Jaundice	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Acute graft versus host disease in intestine	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Engraftment syndrome	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0011 affected22 at risk
Graft versus host disease	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0013 affected22 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Adenovirus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
BK virus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0012 affected22 at risk
Bacterial infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Catheter related infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Cellulitis orbital	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Central line infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0013 affected22 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected22 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Herpes simplex	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Human polyomavirus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Lung infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Oral candidiasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected22 at risk
Oral herpes	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Pneumonia fungal	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected22 at risk
Sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0013 affected22 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Staphylococcal infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0011 affected22 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Urethritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Varicella	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Ear abrasion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Refractoriness to platelet transfusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Blood bilirubin increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0012 affected22 at risk
Blood cortisol decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Blood creatinine increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0012 affected22 at risk
Blood pressure systolic increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Blood triglycerides increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Blood urea increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected22 at risk
Breath sounds abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
CSF protein increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Cardiac function test abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Cytomegalovirus test positive	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Hepatic enzyme increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0013 affected22 at risk
Immunosuppressant drug level increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Oxygen saturation decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0015 affected22 at risk
Transaminases increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Virus urine test positive	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected22 at risk
Weight decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
White blood cell count increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0013 affected22 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected26 at risk EG0015 affected22 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0014 affected22 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected22 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected22 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0010 affected22 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0013 affected22 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0015 affected22 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0015 affected22 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Burning sensation	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected22 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Drooling	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Dystonia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Encephalopathy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected26 at risk EG0013 affected22 at risk
Mental impairment	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Myoclonus	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Neuralgia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Nystagmus	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Paraesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Sedation	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Tremor	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Agitation	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected22 at risk
Confusional state	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Depression	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Drug dependence	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Flat affect	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0013 affected22 at risk
Mental status changes	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Nightmare	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Restlessness	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected22 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Dysuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0016 affected22 at risk
Glycosuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0015 affected22 at risk
Ketonuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected22 at risk
Micturition disorder	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Oliguria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected22 at risk
Proteinuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0012 affected22 at risk
Renal impairment	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0012 affected22 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Scrotal pain	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Vulvovaginal discomfort	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0014 affected22 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0013 affected22 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0011 affected22 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected22 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0013 affected22 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected22 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected26 at risk EG0015 affected22 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0013 affected22 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected26 at risk EG0013 affected22 at risk
Rash morbilliform	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0012 affected22 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected22 at risk
Refusal of treatment by patient	Social circumstances	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Oxygen supplementation	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Capillary leak syndrome	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk
Flushing	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected22 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected26 at risk EG0016 affected22 at risk
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected26 at risk EG0015 affected22 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected22 at risk

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Voriconazole IV	Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).			4	26	26	26
EG001	Voriconazole Oral	Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).			4	22	22	22