Antonilli 2016.
Methods | Uncontrolled phase I/II | |
Participants | 14 high‐risk, disease‐free ovarian cancer (n = 7) or breast carcinoma participants + 3 recurrent OC patients vaccinated for compassionate use | |
Interventions | Triple peptide (MUC1, ErbB2, and CEA) with Montanide vaccine | |
Outcomes | Safety Immune response Clinical 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 | Not explicitly stipulated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not explicitly stipulated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in analysis |
Selective reporting (reporting bias) | Unclear risk | Study protocol not publicly available |
Other bias | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |