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. 2018 Sep 10;2018(9):CD007287. doi: 10.1002/14651858.CD007287.pub4

O'Cearbhaill 2016.

Methods Uncontrolled phase I
Participants 24 participants with advanced‐stage, first‐remission ovarian cancer
Interventions Dose escalation ‐ 25, 50, 100 mcg ‐ unimolecular pentavalent carbohydrate vaccine (Globo‐H, GM2, sTn, TF and Tn in QS‐21)
Outcomes Safety
Immune response
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’