Leffers 2009a.
Methods | Uncontrolled phase II study | |
Participants | 20 women with epithelial ovarian cancer with (biochemical) recurrence not (yet) eligible for renewed chemotherapy | |
Interventions | Subcutaneous synthetic long peptides (p53) Adjuvant: Montanide ISA51 |
|
Outcomes | Survival (disease‐specific survival) Tumour responses Immune responses: humoral, 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 | IInformation 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’ |