Odunsi 2007.
Methods | Uncontrolled phase I study | |
Participants | 18 ovarian cancer patients after chemotherapy for primary or recurrent disease with or without residual disease | |
Interventions | Subcutaneous short peptide (NY‐ESO‐1) Adjuvant: incomplete Freund's adjuvant |
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Outcomes | Survival: median time to progression: 19.0 months Tumour responses: 1× CR, 17× unknown Immune responses: humoral, cellular Adverse events: well tolerated, no further description |
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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’ |