Dijkgraaf 2015.
Methods | Controlled phase I/II trial | |
Participants | 15 participants with platinum‐resistant ovarian cancers expressing 'mutant' p53 | |
Interventions | C1: 6 cycles of gemcitabine (n = 3) C2: 6 cycles of gemcitabine and interferon alpha‐2b 7 days before and 22 days after first cycle of gemcitabine (n = 6) C3: 6 cycles of gemcitabine and interferon alpha‐2b with p53 SLP vaccine 7 days before and 22 days after first cycle of gemcitabine (n = 6) |
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Outcomes | Immune response Safety Clinical response |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Not randomised to treatment groups |
Allocation concealment (selection bias) | High risk | Sequencial allocation to treatment groups |
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 | Low risk | No other sources of bias detected |