Maher 1994.
| Study characteristics | ||
| Methods | Placebo‐controlled, industry‐funded, multicenter trial | |
| Participants | Adults; mixed tumors; ANC < 1 x 109/L | |
| Interventions | G‐CSF (filgrastim) 12 mcg/kg SC ATB: Piperacilin plus Tobramicin |
|
| Outcomes | Overall mortality People with hospitalization for greater than 10 days Bone and joint pain or flu‐like symptoms Time to neutrophil recovery | |
| Notes | Hospital discharge criteria: afebrile for at least 96 hours; ANC at least 500/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 not provided |
| Allocation concealment (selection bias) | Low risk | The randomization code was maintained by the Biostatistical Department of Amgen, Inc., and was not broken until all collected data had been verified by Amgen and its designee, Biomedicus, and had been audited by a separate department at Amgen |
| 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 |