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 |
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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 |