Garcia‐Carbonero 2001.
| Study characteristics | ||
| Methods | Not placebo‐controlled, industry‐ and public‐sponsored, multicenter trial | |
| Participants | Adults; mixed tumors; ANC < 0.5 x 109/L | |
| Interventions | G‐CSF (not specified) 5 mcg/kg SC ATB: Amikacin plus Ceftazidime |
|
| Outcomes | Overall mortality Infection‐related mortality People with hospitalization for greater than 10 days Time to neutrophil recovery Deep vein thrombosis | |
| Notes | Hospital discharge criteria: afebrile for at least 48 hours; ANC at least 1000/mm3 Duration of grade IV neutropenia reported as days to ANC > 500mm3 |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Sequence was computer generated |
| Allocation concealment (selection bias) | Low risk | Participants were randomly assigned by the consecutive drawing of sequentially numbered, opaque, sealed envelopes |
| Blinding (performance bias and detection bias) All outcomes | High risk | There was no blinding |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | There was no blinding |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | There was no blinding |
| 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 |