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 |
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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 |
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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 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 |