Sabbatini 2012.
Methods | Uncontrolled phase I study | |
Participants | 28 ovarian cancer patients in second or third remission | |
Interventions | Subcutaneous overlapping long peptides (NY‐ESO‐1) Adjuvant: cohort 1 ‐ no (n = 4); cohort 2: Montanide ISA‐51 (n = 13); cohort 3: poly‐ICLC in Montanide ISA‐51 (n = 11) |
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Outcomes | Survival (time to progression) Tumour responses Immune responses: cellular and humoral 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’ |