Skip to main content
. 2018 Sep 10;2018(9):CD007287. doi: 10.1002/14651858.CD007287.pub4

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
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