Berek 2009.
Methods | Randomised placebo‐controlled phase III trial | |
Participants | 371 stage III/IV ovarian cancer patients with complete clinical response to primary therapy | |
Interventions | Intravenous monoclonal antibody (oregovomab) vs placebo | |
Outcomes | Survival (time to relapse) Immune responses 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 procedure |
Allocation concealment (selection bias) | Low risk | Centralised randomisation procedure |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded to treatment assignment, post‐randomisation immune responses, and CA‐125 measurements |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded to treatment assignment, post‐randomisation immune responses, and CA‐125 measurements |
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 sources of bias detected |