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. 2010 Feb 17;2010(2):CD006343. doi: 10.1002/14651858.CD006343.pub2
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