Chu 2012.
Methods | Randomised controlled phase I/II study | |
Participants | 14 ovarian cancer patients with complete clinical response to primary therapy (10 received treatment so far) | |
Interventions | Intradermal peptide pulsed dendritic cells (Her‐2/Neu, hTERT, PADRE): vaccine alone vs single dose of cyclophosphamide before first vaccination | |
Outcomes | Tumour responses Immune response Adverse events |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information about the sequence generation process insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Allocation concealment (selection bias) | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding or incomplete blinding, but review authors judge that the outcome is not likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups |
Selective reporting (reporting bias) | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Other bias | High risk | Early termination due to financial limitations |