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

Vellenga 1996.

Study characteristics
Methods Placebo‐controlled, public‐ and industry‐funded, multicenter trial
Participants Adults; mixed tumors; ANC < 0.5 x 109/L
Interventions GM‐CSF (Sandoz) 5 mcg/kg SC
ATB: Imipenem, cefuroxime in combination with an aminoglycoside, Augmentin in combination with an aminoglycoside, and Ceftazidime
Outcomes Overall mortality
Infection‐related mortality
Duration of hospitalization
Deep vein thrombosis
Bone and joint pain or flu‐like symptoms
Notes Hospital discharge criteria: afebrile for at least 72 hours; ANC at least 1000/mm3
Duration of grade IV neutropenia reported as median number of days of neutropenia ANC < 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 is not provided
Allocation concealment (selection bias) Unclear risk Description of method of allocation concealment is not provided
Blinding (performance bias and detection bias)
All outcomes Low risk Double blinding was employed
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk We were not able to assess who were blinded based on the information provided in the article
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