Ströhlein 2009.
Methods | Uncontrolled phase I study | |
Participants | 9 patients with progressive peritoneal carcinomatosis (ovarian cancer n = 2) | |
Interventions | Intraperitoneal trifunctional antibody targeting EpCAM (n = 1) or Her‐2/Neu (n = 1) | |
Outcomes | Survival: not reported separately for ovarian cancer patients Tumour responses Immune responses: cellular, humoral (HAMA) Adverse events |
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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’ |