Ravaud 1998.
| Study characteristics | ||
| Methods | Not placebo‐controlled, industry‐funded, multicenter trial | |
| Participants | Adults; solid tumors; ANC < 1 x 109/L | |
| Interventions | GM‐CSF (molgramostim) 5 mcg/kg SC ATB: Amikacin plus Ceftriaxone OR Piperacilin plus Ofloxacin for people receiving Cisplatin |
|
| Outcomes | Overall mortality Infection‐related mortality Bone and joint pain or flu‐like symptoms Time to neutrophil recovery | |
| Notes | Hospital discharge criteria: afebrile for at least 24 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 | We were not able to assess the adequacy of allocation concealment based on the information provided in the article |
| 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 |