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’ |