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. 2014 Oct 30;2014(10):CD003039. doi: 10.1002/14651858.CD003039.pub2

Mitchell 1997.

Study characteristics
Methods Placebo‐controlled, industry‐funded, multicenter trial
Participants Children; mixed tumors; ANC < 0.5 x 109/L
Interventions G‐CSF (filgrastim) 5 mcg/kg IV
ATB: Gentamicin plus Piperacilin plus Flucloxacilin OR Gentamicin plus Imipenen‐Cilastatin
Outcomes Overall mortality
People with hospitalization for greater than 10 days
Time to neutrophil recovery
Notes Hospital discharge criteria: afebrile for at least 72 hours; ANC at least 200/mm3
Duration of grade IV neutropenia reported as days to absolute granulocyte recovery to > 0.5 x 109/L
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Description of method of sequence generation not provided
Allocation concealment (selection bias) Low risk The study drug and placebo were delivered to the ward in identically labeled syringes, and the staff and investigators were unaware of treatment allocation until the study had been completed.
Blinding (performance bias and detection bias)
All outcomes Low risk Double blinding was employed
Blinding of participants and personnel (performance bias)
All outcomes Low risk Staff and investigators were unaware of treatment allocation until the study had been completed
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk We were not able to assess the outcomes for which blinding was employed based on the information provided in the article
Incomplete outcome data (attrition bias)
All outcomes Low risk ITT analysis used, withdrawals are described
Other bias Low risk Prespecified values of sample size, alpha and beta errors were provided