Baumann 2011.
Methods | Randomised controlled phase II trial | |
Participants | 45 ovarian cancer patients with evidence of disease after first‐ or second‐line chemotherapy | |
Interventions | Intraperitoneal trifunctional bispecific antibody (catumaxomab ‐ EpCAM): low dose (10‐10‐10‐10 μg) vs high dose (10‐20‐50‐100 μg) | |
Outcomes | Tumour responses Survival (progression‐free survival/overall survival) Immune responses: humoral (HAMA) Adverse events |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation list |
Allocation concealment (selection bias) | Unclear risk | Not explicitly stipulated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Data insufficient to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar reasons for missing data across groups |
Selective reporting (reporting bias) | Unclear risk | Study protocol not publicly available |
Other bias | Low risk | No other sources of bias detected |