Lennerz 2014.
Methods | Randomized phase I | |
Participants | 49 participants with survivin expressing solid tumours (ovarian cancer n = 7) | |
Interventions | Three dosage groups of EMD640744 vaccine (5 HLA class I‐binding survivin peptides in Montanide ISA 62 VG) | |
Outcomes | Immune response Safety Clinical response |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised between 3 dosage groups |
Allocation concealment (selection bias) | Unclear risk | Randomised trial |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study |
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 | Low risk | No other forms of bias detected |