Voriconazole Versus Itraconazole In Primary Prophylaxis O... | NCT00289991

Label	Type	Description	Intervention Names
Itraconazole	Active Comparator		Drug: Itraconazole
Voriconazole	Experimental		Drug: Vfend - voriconazole

Name	Type	Description	Arm Group Labels	Other Names
Itraconazole	Drug	Prophylaxis	Itraconazole
Vfend - voriconazole

Measure	Description	Time Frame
Success at Day 180: Percent of Responders (Randomization Strata)	Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).	Day 180 (Visit 9)

Measure	Description	Time Frame
Success at Day 100: Percent of Responders (Randomization Strata)	Percent of responders (by randomization strata) with success of antifungal prophylaxis at 100 days after allogeneic HSCT. Success defined as: alive at Day 100 (Visit 7), had not developed a breakthrough proven or probable IFI by Visit 7, and received full course of study drug prophylaxis without an interruption of >14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 7, imputed as failure at Visit 7 (programmatically).

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Vancouver	British Columbia	V5Z 1M9	Canada
Pfizer Investigational Site

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

ID	Title	Description
FG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen intravenous (IV) for first 24 hours: 6 milligrams per kilogram (mg/kg) of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) twice daily (BID) or 200 mg tablet or powder for oral suspension by mouth (PO) BID (subjects greater than or equal to [≥] 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects less than [<] 40 kg body weight).

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

Success at Day 180: Percent of Responders (Randomization Strata)

Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).

Modified Intent to Treat (MITT): primary analysis population; all randomized subjects: received at least 1 dose of randomized study drug and had allogeneic HSCT; data from 1 site excluded due to Good Clinical Practice (GCP) deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.

Posted

Number

percent of participants

Day 180 (Visit 9)

ID	Title	Description
OG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
OG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Units	Counts
Participants	OG000224 OG001241

Title

Denominators

Categories

Myeloablative/matched related (n=66, 85)

Title	Measurements
	OG00059.1 OG00144.7

Myeloablative/mismatched unrelated (n=59, 58)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Non-inferiority inferred if lower limit of the 2-sided 95 percent (%) confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as "Success" at Day 180 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as "Success" at Day 180 after transplant does not include zero and is positive.	Difference in adjusted responder rates	Difference in adjusted responder rates using Fleiss method			percent difference adjusted proportions	16.4			2-Sided	95	7.7	25.1			Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.

Secondary

Success at Day 100: Percent of Responders (Randomization Strata)

Percent of responders (by randomization strata) with success of antifungal prophylaxis at 100 days after allogeneic HSCT. Success defined as: alive at Day 100 (Visit 7), had not developed a breakthrough proven or probable IFI by Visit 7, and received full course of study drug prophylaxis without an interruption of >14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 7, imputed as failure at Visit 7 (programmatically).

MITT; data from 1 site excluded due to GCP deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.

Posted

Number

percent of participants

Day 100 (Visit 7)

ID	Title	Description
OG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
OG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Secondary

Time to Breakthrough Invasive Fungal Infection (IFI)

Summary of time (in days) from start of prophylaxis to first recorded occurrence of breakthrough proven or probable IFI.

MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) worksheets (not on Case Report Forms or in the database). Times were summarized only for subjects who experienced a breakthrough IFI.

Posted

Mean

95% Confidence Interval

days

Day 1 up to Day 180 (Visit 9)

ID	Title	Description
OG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
OG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Units	Counts

Secondary

Percent of Subjects With Occurrence of Breakthrough IFI

Percent of subjects with occurrence of breakthrough IFI (proven or probable). Included all subjects in the MITT population.

MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on EORTC/MSG worksheets (not on Case Report Forms or in the database).

Posted

Number

percent of participants

Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)

ID	Title	Description
OG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
OG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Units	Counts
Participants

Secondary

Survival: Percent of Subjects Who Died at or Before Day 180

Percent of subjects who died at or before Day 180, derived from the crude death rate. All subjects in the MITT population included in this proportion.

MITT; data from 1 site excluded due to GCP deviations. Analysis does not include any deaths recorded in the long-term follow-up data (not available at time of analysis).

Posted

Number

percent of participants

Day 1 up to Day 180 (Visit 9)

ID	Title	Description
OG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
OG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Units	Counts
Participants

Secondary

Time to Discontinuation of Study Treatment

Time in days to discontinuation of study treatment defined as the number of days from first dose to last dose inclusive as recorded in the dosing log.

MITT; data from 1 site excluded due to GCP deviations.

Posted

Mean

95% Confidence Interval

days

Day 1 up to Day 180 (Visit 9)

ID	Title	Description
OG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
OG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Units	Counts
Participants	OG000

Secondary

Survival: Percent of Subjects Who Died Within 1 Year

Percent of subjects who died within 1 year after transplant, derived from the crude death rate. All subjects in the MITT population included in this proportion. Only deaths up until and including 365 days after first dose of study medication included in the analysis.

MITT; data from 1 site excluded due to GCP deviations. Typically, subjects received first dose study treatment on the day of their transplant; however, some subjects started treatment up to 48 hours after transplant. Data summarized with first day of study medication defined as Day 1.

Posted

Number

percent of participants

Day 1 up to 1 year (Day 365)

ID	Title	Description
OG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
OG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Secondary

Duration of Treatment

Median duration in days of treatment. Treatment is defined as the total number of days on which subjects took medication.

MITT; data from 1 site excluded due to GCP deviations.

Posted

Median

Full Range

days

Day 1 up to Day 180

ID	Title	Description
OG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
OG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Units	Counts
Participants	OG000

Secondary

Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment

Percent of subjects who used other systemic antifungal agents as empirical or therapeutic treatment, defined as either empirical: subject took a systemic antifungal agent at any time after the day of first dose of medication and did not develop a breakthrough proven or probable IFI during the study or therapeutic: subject developed a breakthrough proven or probable IFI.

MITT; data from 1 site excluded due to GCP deviations. Subjects who developed a breakthrough proven or probable IFI were identified only from the study database, not the EORTC/MSG worksheet. In addition, all agents identified to be antifungals were considered to be systemic.

Posted

Number

percent of participants

Day 1 up to Day 180

ID	Title	Description
OG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
OG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected234 at risk EG0012 affected255 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Autoimmune thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0014 affected255 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Cardiac failure	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Photopsia	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Vision blurred	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Disbacteriosis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Caecitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Colitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0008 affected234 at risk EG0019 affected255 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0012 affected255 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0016 affected255 at risk
Retching	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0017 affected255 at risk
Ileus	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Hyperthermia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Pyrexia	General disorders	MedDRA (12.0)	Systematic Assessment	EG00019 affected234 at risk EG00111 affected255 at risk
Asthenia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Chills	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Disease progression	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Fatigue	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
General physical health deterioration	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Mucosal inflammation	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Multi-organ failure	General disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected234 at risk EG0013 affected255 at risk
Oedema	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Performance status decreased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Drug intolerance	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Drug withdrawal syndrome	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0010 affected255 at risk
Chronic hepatitis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0010 affected255 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected234 at risk EG0011 affected255 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0011 affected255 at risk
Venoocclusive liver disease	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0011 affected255 at risk
Acute graft versus host disease	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0017 affected255 at risk
Acute graft versus host disease in intestine	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected234 at risk EG0016 affected255 at risk
Acute graft versus host disease in liver	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected234 at risk EG0011 affected255 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Bone marrow transplant rejection	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Chronic graft versus host disease	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0013 affected255 at risk
Graft versus host disease	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0009 affected234 at risk EG0018 affected255 at risk
Transplant rejection	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Bacterial infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Clostridial infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Escherichia sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Klebsiella infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Klebsiella sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Pseudomonas infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Staphylococcal infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0012 affected255 at risk
Stenotrophomonas infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Aspergillosis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Fungal infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Bacteraemia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Catheter related infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Central line infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 affected234 at risk EG0010 affected255 at risk
Ear infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Gastroenteritis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Lung infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0013 affected255 at risk
Pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0004 affected234 at risk EG0014 affected255 at risk
Respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 affected234 at risk EG0014 affected255 at risk
Septic shock	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0014 affected255 at risk
Sinusitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
BK virus infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Bronchiolitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Cytomegalovirus gastrointestinal infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0009 affected234 at risk EG00111 affected255 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Herpes zoster	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Human herpesvirus 6 infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Meningoencephalitis herpetic	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Metapneumovirus infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Oral herpes	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Viral infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Lung injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0011 affected255 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Haematocrit decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Haemoglobin decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Alanine aminotransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0013 affected255 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0012 affected255 at risk
Blood bilirubin increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Hepatic enzyme increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Liver function test abnormal	Investigations	MedDRA (12.0)	Systematic Assessment	EG0004 affected234 at risk EG0010 affected255 at risk
Cytomegalovirus antigen positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Cytomegalovirus test	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0012 affected255 at risk
Cytomegalovirus test positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0011 affected255 at risk
Gram stain positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Respiratory syncytial virus test positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Weight	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Weight decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0011 affected255 at risk
Blood creatinine increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Serum ferritin increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Acute myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0014 affected255 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0013 affected255 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Disseminated large cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0010 affected255 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Meningorrhagia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Leukoencephalopathy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Cognitive disorder	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Monoplegia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Parkinsonism	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Dizziness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Lethargy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Loss of consciousness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Nervous system disorder	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Presyncope	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Convulsion	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0010 affected255 at risk
Confusional state	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Depression	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Hallucination, visual	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0010 affected255 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected234 at risk EG0016 affected255 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0012 affected255 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected234 at risk EG0011 affected255 at risk
Renal impairment	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Dysuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Obliterative bronchiolitis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0010 affected255 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0012 affected255 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0011 affected255 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0013 affected255 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected234 at risk EG0015 affected255 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0012 affected255 at risk
Subdural haematoma evacuation	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Extremity necrosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0011 affected255 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected234 at risk EG0011 affected255 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk
Venous thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected234 at risk EG0010 affected255 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG00030 affected234 at risk EG00130 affected255 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG00035 affected234 at risk EG00141 affected255 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG00051 affected234 at risk EG00168 affected255 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG00021 affected234 at risk EG00130 affected255 at risk
Tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00013 affected234 at risk EG0016 affected255 at risk
Visual impairment	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00015 affected234 at risk EG0012 affected255 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00041 affected234 at risk EG00121 affected255 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG000100 affected234 at risk EG001132 affected255 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00012 affected234 at risk EG0015 affected255 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00045 affected234 at risk EG00150 affected255 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00023 affected234 at risk EG00121 affected255 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00025 affected234 at risk EG00122 affected255 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00086 affected234 at risk EG00191 affected255 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00078 affected234 at risk EG001103 affected255 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00012 affected234 at risk EG00110 affected255 at risk
Oral pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00015 affected234 at risk EG00112 affected255 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00017 affected234 at risk EG00117 affected255 at risk
Catheter related complication	General disorders	MedDRA (12.0)	Systematic Assessment	EG00011 affected234 at risk EG00113 affected255 at risk
Catheter site erythema	General disorders	MedDRA (12.0)	Systematic Assessment	EG00016 affected234 at risk EG00110 affected255 at risk
Pyrexia	General disorders	MedDRA (12.0)	Systematic Assessment	EG000105 affected234 at risk EG001101 affected255 at risk
Asthenia	General disorders	MedDRA (12.0)	Systematic Assessment	EG00019 affected234 at risk EG00131 affected255 at risk
Chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG00013 affected234 at risk EG00111 affected255 at risk
Chills	General disorders	MedDRA (12.0)	Systematic Assessment	EG00017 affected234 at risk EG00123 affected255 at risk
Fatigue	General disorders	MedDRA (12.0)	Systematic Assessment	EG00035 affected234 at risk EG00119 affected255 at risk
Mucosal inflammation	General disorders	MedDRA (12.0)	Systematic Assessment	EG000115 affected234 at risk EG001142 affected255 at risk
Oedema	General disorders	MedDRA (12.0)	Systematic Assessment	EG00013 affected234 at risk EG00113 affected255 at risk
Oedema peripheral	General disorders	MedDRA (12.0)	Systematic Assessment	EG00037 affected234 at risk EG00142 affected255 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG00014 affected234 at risk EG00110 affected255 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG00015 affected234 at risk EG0018 affected255 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG00019 affected234 at risk EG0018 affected255 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected234 at risk EG00113 affected255 at risk
Acute graft versus host disease	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG00012 affected234 at risk EG00116 affected255 at risk
Graft versus host disease	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG00036 affected234 at risk EG00136 affected255 at risk
Folliculitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00012 affected234 at risk EG00111 affected255 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00012 affected234 at risk EG0018 affected255 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00022 affected234 at risk EG00117 affected255 at risk
Haemoglobin decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG00013 affected234 at risk EG0018 affected255 at risk
Alanine aminotransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG00012 affected234 at risk EG0014 affected255 at risk
Liver function test abnormal	Investigations	MedDRA (12.0)	Systematic Assessment	EG00017 affected234 at risk EG0019 affected255 at risk
Weight increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG00010 affected234 at risk EG00113 affected255 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00019 affected234 at risk EG00125 affected255 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0009 affected234 at risk EG00118 affected255 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00021 affected234 at risk EG00130 affected255 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected234 at risk EG00117 affected255 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00014 affected234 at risk EG00118 affected255 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00012 affected234 at risk EG00130 affected255 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00012 affected234 at risk EG00112 affected255 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00012 affected234 at risk EG0018 affected255 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00018 affected234 at risk EG00122 affected255 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00033 affected234 at risk EG00127 affected255 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00021 affected234 at risk EG00124 affected255 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG00063 affected234 at risk EG00169 affected255 at risk
Tremor	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG00011 affected234 at risk EG00119 affected255 at risk
Dizziness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG00013 affected234 at risk EG0019 affected255 at risk
Paraesthesia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG00014 affected234 at risk EG0015 affected255 at risk
Anxiety	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG00015 affected234 at risk EG00118 affected255 at risk
Insomnia	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG00023 affected234 at risk EG00117 affected255 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG00019 affected234 at risk EG00112 affected255 at risk
Dysuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG00013 affected234 at risk EG00115 affected255 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00045 affected234 at risk EG00142 affected255 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00017 affected234 at risk EG00113 affected255 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00021 affected234 at risk EG00122 affected255 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00016 affected234 at risk EG00116 affected255 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00020 affected234 at risk EG00130 affected255 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00016 affected234 at risk EG00112 affected255 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00043 affected234 at risk EG00139 affected255 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00025 affected234 at risk EG00124 affected255 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00048 affected234 at risk EG00145 affected255 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0007 affected234 at risk EG00113 affected255 at risk
Hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG00016 affected234 at risk EG00118 affected255 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG00044 affected234 at risk EG00149 affected255 at risk

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D010879	Piperazines

ID	Title	Description
BG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
BG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).			111	234	228	234
EG001	Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.			95	255	252	255