Study Of The Pharmacokinetics And Safety Of Voriconazole... | NCT00739934

Label	Type	Description	Intervention Names
Children aged 2 to <12 years	Experimental	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection.	Drug: voriconazole (Vfend)

Name	Type	Description	Arm Group Labels	Other Names
voriconazole (Vfend)	Drug	Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h Notes: If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose. Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30. (IV = Intravenous; POS = Powder for oral suspension)

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 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration		Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Time to Reach Cmax (Tmax) Following IV Administration		Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
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 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Cmax,ss Following Oral Administration		Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Tmax Following Oral Administration		Day 7 (or later) 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 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Cmax Following an IV Loading Dose

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Tucson	Arizona	85719	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	All Participants	Voriconazole intravenous (IV) multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).

ID	Title	Description
BG000	All Participants	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	BG00040

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 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).

Units	Counts
Participants	OG00036

Title

Denominators

Categories

Title	Measurements
	OG00021.42± 35.05

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 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).

Units	Counts
Participants	OG00036

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 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).

Units	Counts
Participants	OG00036

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 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Voriconazole oral dose (200 mg) was administered in the morning and evening 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 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG00033

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 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG00033

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 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.

Units	Counts
Participants	OG000

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 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.

Units	Counts
Participants	OG00033

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 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.

Units	Counts
Participants	OG00033

Secondary

Trough Concentrations (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 or more) for IV; Day 7 (or later) for oral at predose

ID	Title	Description
OG000	All Treatments	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening 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

Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more 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

Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).

Units	Counts
Participants	OG000

Secondary

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

Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.

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

Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole IV	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more 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

Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Voriconazole oral dose (200 mg) was administered in the morning and evening 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 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG00033

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 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose

ID	Title	Description
OG000	Voriconazole Oral	Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Units	Counts
Participants	OG00033

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0011 affected34 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected40 at risk EG0014 affected34 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Bradycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0012 affected34 at risk
Dilatation ventricular	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0011 affected34 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Factor VII deficiency	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0010 affected34 at risk
Cushingoid	Endocrine disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Astigmatism	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Blindness	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Colour blindness acquired	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Conjunctivitis	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0012 affected34 at risk
Dry eye	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0011 affected34 at risk
Eye irritation	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Eye pain	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Eye pruritus	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Lacrimation decreased	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Myopia	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Vision blurred	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Visual acuity reduced	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0012 affected34 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0011 affected34 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0009 affected40 at risk EG0019 affected34 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Ascites	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected40 at risk EG0017 affected34 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected40 at risk EG0016 affected34 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0012 affected34 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0010 affected34 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Gingival hypertrophy	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0012 affected34 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Lip dry	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Lip ulceration	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0016 affected34 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Oral pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0012 affected34 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0011 affected34 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected40 at risk EG0014 affected34 at risk
Catheter related complication	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Catheter site erythema	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Catheter site haemorrhage	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Catheter site pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Chills	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Drug withdrawal syndrome	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0012 affected34 at risk
Face oedema	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Facial pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0013 affected34 at risk
Gravitational oedema	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Irritability	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0013 affected34 at risk
Localised oedema	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Mucosal inflammation	General disorders	MedDRA 12.1	Systematic Assessment	EG00020 affected40 at risk EG00111 affected34 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected40 at risk EG0014 affected34 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG00015 affected40 at risk EG00111 affected34 at risk
Suprapubic pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0011 affected34 at risk
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected40 at risk EG0014 affected34 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Engraftment syndrome	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected40 at risk EG0012 affected34 at risk
Graft versus host disease	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0014 affected34 at risk
Hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Alpha haemolytic streptococcal infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Bacterial infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0010 affected34 at risk
Bacterial sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0012 affected34 at risk
Candidiasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Clostridial infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0012 affected34 at risk
Cystitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0013 affected34 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0013 affected34 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Enterococcal infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0012 affected34 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Gastroenteritis adenovirus	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0012 affected34 at risk
Herpes virus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Human herpesvirus 6 infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Oral candidiasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0014 affected34 at risk
Paronychia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Rhinovirus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0014 affected34 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Urinary tract infection viral	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Viraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Viral rhinitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Graft complication	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Suture related complication	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Alanine aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0006 affected40 at risk EG0018 affected34 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0005 affected40 at risk EG0017 affected34 at risk
Bacteria blood identified	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Bacteria stool identified	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Blood albumin decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Blood bicarbonate decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Blood bilirubin increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0013 affected34 at risk
Blood creatinine increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Blood immunoglobulin G decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Blood pressure increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Blood urea increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0010 affected34 at risk
CSF virus identified	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Chest X-ray abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Clostridium difficile toxin test positive	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Cytomegalovirus test positive	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0015 affected34 at risk
Heart rate increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Hepatic enzyme decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Hepatic enzyme increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0014 affected34 at risk
Human herpes virus 6 serology positive	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Lipase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Liver function test abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Oxygen saturation decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0004 affected40 at risk EG0013 affected34 at risk
Transaminases increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Urine cytomegalovirus	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Urine output decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0012 affected34 at risk
Virus urine test positive	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0012 affected34 at risk
Visual tracking test abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Weight decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Weight increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
White blood cell count decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected40 at risk EG0016 affected34 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0008 affected40 at risk EG0014 affected34 at risk
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected40 at risk EG0015 affected34 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected40 at risk EG0011 affected34 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0012 affected34 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected40 at risk EG0013 affected34 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0014 affected34 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0012 affected34 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0010 affected34 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0012 affected34 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0012 affected34 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0013 affected34 at risk
Malignant mesenchymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Burning sensation	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected40 at risk EG0013 affected34 at risk
Lethargy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0012 affected34 at risk
Somnolence	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0012 affected34 at risk
Tremor	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Aggression	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Agitation	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0012 affected34 at risk
Anxiety	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Confusional state	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Hallucination	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Staring	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0012 affected34 at risk
Dysuria	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected40 at risk EG0016 affected34 at risk
Glycosuria	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Haematuria	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0014 affected34 at risk
Oliguria	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0012 affected34 at risk
Pyelocaliectasis	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Renal impairment	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Urethral pain	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Genital erythema	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0012 affected34 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0015 affected34 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Nasal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Paranasal sinus mucosal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected40 at risk EG0012 affected34 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected40 at risk EG0017 affected34 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0012 affected34 at risk
Periorbital oedema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG00012 affected40 at risk EG00110 affected34 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0008 affected40 at risk EG0019 affected34 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0012 affected34 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected40 at risk EG0013 affected34 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected34 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Capillary leak syndrome	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected34 at risk
Haemorrhage	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG00013 affected40 at risk EG00110 affected34 at risk
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected34 at risk
Venoocclusive disease	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected34 at risk

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections
D058365	Candidiasis, Invasive
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
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 multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).			6	40	39	40
EG001	Voriconazole Oral	Voriconazole oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).			13	34	34	34