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. 2017 Aug 29;2017(8):CD004064. doi: 10.1002/14651858.CD004064.pub4

Van Cutsem 2015.

Methods Prospective, multinational, randomised, phase II study
Fifty‐two sites in the USA and 11 countries in Europe screened and randomised patients
Participants The majority (69%) of patients were male; mean age was 59 years
Interventions 3‐arm study: docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5‐FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX)
Outcomes PFS
OS
ORR
Safety
Notes "Tumour response was evaluated every 8 weeks and classified according to best overall response (World Health Organization criteria). Responses were confirmed by two evaluations conducted ≥4 weeks apart"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not clear what method
Allocation concealment (selection bias) Low risk RandomiSed centrally using an interactive voice response system
Incomplete outcome data (attrition bias) 
 efficacy Low risk "primary efficacy population was the full analysis population (FAP: all randomized and treated patients analysed in the arm to which they were randomized), with supportive analyses conducted using the intent‐to‐treat (ITT: all randomized patients) and per protocol (PP: assessable patients [received study treatment and had ≥1 post‐baseline tumour assessment] without any major protocol violation) populations"
Incomplete outcome data (attrition bias) 
 safety Low risk "primary efficacy population was the full analysis population (FAP: all randomized and treated patients analysed in the arm to which they were randomized), with supportive analyses conducted using the intent‐to‐treat (ITT: all randomized patients) and per protocol (PP: assessable patients [received study treatment and had ≥1 post‐baseline tumour assessment] without any major protocol violation) populations"
Selective reporting (reporting bias) Low risk PFS, OS, ORR, safety
Other bias Unclear risk N/A
Blinded review of CT/MRI‐scans? Unclear risk Not stated