Sabbatini 2006.
Methods | Randomised open‐label multi‐centre phase I study | |
Participants | 42 stage II‐IV ovarian cancer patients after chemotherapy for recurrence of disease with complete clinical response or measurable disease (< 2 cm) | |
Interventions | Intramuscular (IM) or subcutaneous (SC) monoclonal antibody (abagovomab ‐ CA‐125): 4 cohorts (2× IM; 2× SC; 0.2 mg or 2 mg) | |
Outcomes | Survival (time to progression) Tumour responses Immune response: humoral (Ab3, HAMA), cellular Adverse events |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Standard 2 × 2 factorial design |
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 | Unclear risk | Reporting of attrition/exclusions 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 | Low risk | No other sources of bias detected |