A Study Of The Safety, Tolerability And Effective Of Vori... | NCT01092832

ID	Type	Description	Link
2009-012848-16	EudraCT Number

Label	Type	Description	Intervention Names
Active voriconazole	Experimental	All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.	Drug: voriconazole

Name	Type	Description	Arm Group Labels	Other Names
voriconazole	Drug	Subjects 12 - <18 yrs (excluding subjects 12 - 14 yrs weighing <50kg): For IC, the loading dose is 6 mg/kg IV q12h on Day 1, followed by 4 mg/kg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg/kg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h. Subjects 2 - <12 yrs, and subjects 12 - 14 weighing <50kg: For IC, the loading dose is 9 mg/kg IV q12h on Day 1, followed by 8 mg/kg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg/kg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg/kg q12h (maximum initial dose of 300 mg). Subjects will be treated for a minimum of 14 days for invasive candidiasis/candidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days.

Measure	Description	Time Frame
Percentage of Participants With Adverse Events - Overall Summary	Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.	Baseline up to 1 month follow-up

Measure	Description	Time Frame
Percentage of Participants With a Global Response of Success at End of Treatment (EOT)	Global response was determined programmatically based on investigator assessment of clinical and microbiological response. Global response of success was defined as clinical cure or improvement AND microbiological eradication or presumed eradication. Exact 95 percent (%) confidence interval for binomial proportions using Clopper-Pearson method.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female 2 to <18 years of age; Subjects 2 to <12 years of age will be permitted to enroll in this study only after a Pfizer sponsored pharmacokinetic study confirms the proposed dosage corresponding to this age group is appropriate.
Patients with confirmed Candida infection of the blood, body tissues, or the esophagus.
Patient's doctor feels voriconazole is an appropriate choice of therapy.

Exclusion Criteria:

A known allergy to voriconazole or to azole to antifungal drugs.
Females who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of childbearing potential and not using highly effective method of birth control.
A patient who is receiving treatment with a drug know to interfere with the heart's electrical system (QTc prolongation).
A patient who is receiving treatment with a drug that is not permitted to be used with voriconazole.
For primary therapy: a patient who has received more than 48 hours of antifungal therapy for the current episode of Candida infection.
A patient with significant underlying liver disease at the time of enrollment in the study.
A patient with significant renal disease (CrCl < 50 ml/min) at the time of enrollment in the study.
A patient with a high likelihood of death within 72 hours of study enrollment due to factors unrelated to Candida infection.

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

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology		Wuhan	Hubei	430030	China

PubMed Identifier	Type	Citation	Retractions
27636722	Derived	Martin JM, Macias-Parra M, Mudry P, Conte U, Yan JL, Liu P, Capparella MR, Aram JA. Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients With Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis. Pediatr Infect Dis J. 2017 Jan;36(1):e1-e13. doi: 10.1097/INF.0000000000001339.

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

ID	Title	Description
FG000	Voriconazole: 2 to <12 Years	Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) with invasive candidiasis/candidemia (ICC) received a loading dose of voriconazole 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with esophageal candidiasis (EC) received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to oral (PO) therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.

Arm/Group Information

ID	Title	Description
BG000	Voriconazole: 2 to <12 Years	Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
BG001	Voriconazole: 12 to <18 Years	Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00014 BG0018 BG00222

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Adverse Events - Overall Summary

Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.

Safety population

Posted

Number

percentage of participants

Baseline up to 1 month follow-up

ID	Title	Description
OG000	Voriconazole: 2 to <12 Years	Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
OG001	Voriconazole: 12 to <18 Years	Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.

Units	Counts
Participants	OG00014 OG0018

Title

Denominators

Categories

With AEs

Title	Measurements
	OG00092.9 OG00175.0

With SAEs

Title	Measurements
	OG000

Secondary

Percentage of Participants With a Global Response of Success at End of Treatment (EOT)

Global response was determined programmatically based on investigator assessment of clinical and microbiological response. Global response of success was defined as clinical cure or improvement AND microbiological eradication or presumed eradication. Exact 95 percent (%) confidence interval for binomial proportions using Clopper-Pearson method.

Modified Intent-to-Treat (MITT) Population: all participants who received at least 1 dose of study medication and who have confirmed ICC, EC or participants with EC who do not have confirmation of EC by esophagoscopy, but who had at least confirmation of oropharyngeal candidiasis.

Posted

Number

95% Confidence Interval

percentage of participants

EOT (from 7 to 42 days of treatment)

ID	Title	Description
OG000	Voriconazole: 2 to <12 Years	Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.

Secondary

All-Cause Mortality - Number of Participant Deaths

Safety population

Posted

Number

participants

Day 28 and 1 Month Follow-up

ID	Title	Description
OG000	Voriconazole: 2 to <12 Years	Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
OG001	Voriconazole: 12 to <18 Years	Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.

Secondary

Time to Death

No participants died within the safety reporting period, therefore time to death was not applicable.

Posted

Baseline up to 1 month follow-up

ID	Title	Description
OG000	Voriconazole: 2 to <12 Years	Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
OG001	Voriconazole: 12 to <18 Years	Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Voriconazole: 2 to <12 Years	Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.			2	14	13	14
EG001	Voriconazole: 12 to <18 Years	Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.			1	8	6	8

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hypothrombinaemia	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Platelet disorder	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0011 affected8 at risk
Pericardial effusion	Cardiac disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Tachycardia	Cardiac disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Amaurosis	Eye disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Conjunctivitis	Eye disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Corneal opacity	Eye disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Eye pruritus	Eye disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Eyelid disorder	Eye disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Photophobia	Eye disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected14 at risk EG0011 affected8 at risk
Retinal disorder	Eye disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Visual acuity reduced	Eye disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Ascites	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0011 affected8 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0012 affected8 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0011 affected8 at risk
Device occlusion	General disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Hypothermia	General disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected14 at risk EG0011 affected8 at risk
Pyrexia	General disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected14 at risk EG0011 affected8 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Jaundice	Hepatobiliary disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Anorectal cellulitis	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Bone abscess	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Cellulitis	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Oral herpes	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Rhinitis	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Splenic candidiasis	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Refractoriness to platelet transfusion	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Alanine aminotransferase abnormal	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0003 affected14 at risk EG0010 affected8 at risk
Alanine aminotransferase increased	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Aspartate aminotransferase abnormal	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Blood alkaline phophatase abnormal	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Blood triglycerides increased	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Drug level decreased	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Gamma-glutamyltransferase abnormal	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0002 affected14 at risk EG0010 affected8 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Haematocrit abnormal	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hepatic enzyme increased	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Lymphocyte percentage abnormal	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Monocyte count abnormal	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Staphylococcus test positive	Investigations	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0011 affected8 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected14 at risk EG0010 affected8 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0011 affected8 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Paraesthesia	Nervous system disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Haematuria	Renal and urinary disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Testicular mass	Reproductive system and breast disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Dermatosis	Skin and subcutaneous tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0003 affected14 at risk EG0010 affected8 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Hypertension	Vascular disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected14 at risk EG0010 affected8 at risk
Phlebitis	Vascular disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk
Venoocclusive disease	Vascular disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

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

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Pneumonia	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected8 at risk
Splenic candidiasis	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected8 at risk