Reference |
Dichotomous variables |
Definition |
Time point |
Comparator A |
Comparator B |
Number assessed |
Number with outcome |
Number assessed |
Number with outcome |
Primary outcomes |
(1) All cause mortality |
Death of any randomised patient regardless of cause |
End of therapy |
|
|
|
|
Other time point ______________ |
|
|
|
|
(2) IFI related mortality |
Death of a patient diagnosed with IFI whose death is attributable to IFI |
End of therapy |
|
|
|
|
Other time point ______________ |
|
|
|
|
(3) Complete resolution of fungal infection |
Complete resolution of clinical symptoms +/‐ radiological or microbiological findings that led to diagnosis of IFI and enabling cessation of anti‐fungal medication |
End of therapy |
|
|
|
|
Secondary outcomes |
(4) Complete or partial resolution of fungal infection |
Any improvement in clinical symptoms +/‐ radiological findings that led to diagnosis of IFI yet not fulfilling criteria for complete resolution |
End of therapy |
|
|
|
|
(5) Resolution of fever in suspected fungal infection |
Absence of temperature > 38°C for more than 72 hours |
|
|
|
|
(6) Progression of disease requiring change / addition of an antifungal agent |
Progression of existing symptoms +/‐ radiological or microbiological findings that are of enough concern for a clinician to change anti‐fungal dose or add a new anti‐fungal agent |
|
|
|
|
(7) Breakthrough fungal infection requiring change / addition of an antifungal agent |
New clinical symptoms or signs +/‐ radiological or microbiological findings that are of enough concern for clinicians to change antifungal dose or add a new anti‐fungal agent |
|
|
|
|
(8) Any clinically significant adverse reactions attributed to the antifungal agent resulting in discontinuation, dose reduction or change in therapy |
|
|
|
|
|
(9) Any adverse reaction attributed to the antifungal agent including |
|
|
|
|
|
(9a) Abnormal renal function |
≥ 100% rise in serum creatinine |
|
|
|
|
Other definition of nephrotoxicity ________________________ |
|
|
|
|
(9b) electrolyte imbalance |
hypokalaemia < 3.0mmol/L |
|
|
|
|
other definition of hypokalaemia |
|
|
|
|
other definitions of electrolyte imbalance |
|
|
|
|
(9c) abnormal hepatic function |
transaminases > 2x normal values for age |
|
|
|
|
|
Other definition of hepatotoxicity ________________________ |
|
|
|
|
(9d) infusion related reactions |
Any infusion related reactions |
|
|
|
|
Chills (definition ______________________________________) |
|
|
|
|
Fevers (definition ______________________________________) |
|
|
|
|
Other infusion related reaction (definition _______________) |
|
|
|
|
(9e) gastrointestinal disturbances such as nausea, vomiting or diarrhoea |
Any gastrointestinal disturbances |
|
|
|
|
Nausea |
|
|
|
|
Vomiting |
|
|
|
|
Diarrhoea |
|
|
|
|
(9f) neurological disturbances such as blurred vision or dizziness |
Any neurological disturbances |
|
|
|
|
Blurred vision |
|
|
|
|
Dizziness |
|
|
|
|
Other neurological disturbances |
|
|
|
|
(9g) Haematological disturbances such as anaemia, granulocytopaenia or thrombocytopaenia |
Any haematological disturbances |
|
|
|
|
Anaemia (definition ___________________________________) |
|
|
|
|
Granulocytopaenia (definition __________________________) |
|
|
|
|
Thrombocytopaenia (definition _________________________) |
|
|
|
|
|
|
|
|
|
|
|
Dichotomous variables |
Definition |
Time point |
Comparator A |
Comparator B |
Number assessed |
Mean (SD) |
Number assessed |
Mean (SD) |
Secondary outcomes |
(10) Length of stay |
number of days |
|
|
|
|
(11) Quality of life |
QOL (definition________________________________________) |
|
|
|
|
(12) Cost |
$US |
|
|
|
|