Rahma 2012.
Methods | Uncontrolled phase II study | |
Participants | 21 ovarian cancer patients without evidence of disease after prior therapy | |
Interventions | Subcutaneous short peptide (p53) vs intravenous peptide‐pulsed dendritic cells (p53) Adjuvant: Montanide ISA‐51 and GM‐CSF (only in cohort treated with peptide) |
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Outcomes | Survival (progression‐free survival, overall survival) Tumour responses Immune responses: cellular Adverse events |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Uncontrolled trial |
Allocation concealment (selection bias) | High risk | Uncontrolled trial |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
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 | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Selective reporting (reporting bias) | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Other bias | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |