Sabbatini 2013.
Methods | Randomised placebo‐controlled trial | |
Participants | 888 ovarian cancer patients in complete clinical remission after primary therapy | |
Interventions | Subcutaneous monoclonal antibody (abagovomab ‐ CA‐125) | |
Outcomes | Survival (recurrence‐free survival, overall survival) Immune responses: humoral (Ab3, HAMA), cellular (to be reported in separate paper) Adverse events |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Centralised randomisation |
Allocation concealment (selection bias) | Low risk | Centralised randomisation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and key study personnel ensured; unlikely that the blinding could have been broken |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of outcome assessment ensured; unlikely that the blinding could have been broken |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups |
Selective reporting (reporting bias) | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Other bias | Low risk | No other forms of bias detected |