Riikonen 1994.
| Study characteristics | ||
| Methods | Placebo‐controlled, public‐funded, multi‐center trial | |
| Participants | Children, mixed tumors; ANC < 0.2 x 109/L | |
| Interventions | GM‐CSF (Sandoz) 5 mcg/kg IV ATB: Imipenen‐Cilastatin |
|
| Outcomes | Overall mortality Infection‐related mortality Duration of hospitalization Bone and joint pain or flu‐like symptoms | |
| Notes | Hospital discharge criteria: afebrile for at least 72 hours; ANC at least 500/mm3 Duration of grade IV neutropenia reported as days to absolute granulocyte recovery to > 0.5 x 109/L |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | We were not able to assess the adequacy of method of sequence generation based on the information provided in the article |
| 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 | 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 | High risk | ITT analysis not used, withdrawals are described |
| Other bias | Low risk | Prespecified values of sample size, alpha and beta errors were provided |