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. 2018 Sep 10;2018(9):CD007287. doi: 10.1002/14651858.CD007287.pub4

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)
Outcomes Immune response
Safety
Clinical response
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