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. 2012 Oct 17;2012(10):CD006469. doi: 10.1002/14651858.CD006469.pub2

Thigpen 1989.

Methods Randomised Phase II trial
April 1982 to July 1985
Participants 331 women with advanced or recurrent squamous cell cervical cancer no longer amenable to control by surgery or radiotherapy
Interventions Arm 1: cisplatin 50 mg/m2 iv rate 1 mg/minute q21 days
Arm 2: cisplatin 50 mg/m2 iv rate over 24 h q21 days
Outcomes Response rates
OS
PFS
Toxicity
Notes 63 patients deemed ineligible (7 other primary site, 4 second primary, 26 wrong histological subtype, 26 no documentation of cervical primary, 1 elevated blood nitrogen urea at entry, 1 GOG performance status 4 at entry). 6 further patients with unevaluable (1 clerical error at entry, 1 never treated, 1 inadequate pathology, 2 inadequate data submitted, 1 not documented reason for unevaluability)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Latin square arrangement balancing the sequence of assigned regimens within and across institutions
Allocation concealment (selection bias) Unclear risk Not documented
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Not documented but OS unlikely to be affected by blinding
Incomplete outcome data (attrition bias) 
 All outcomes High risk 63 patients excluded as ineligible and further 6 patients were unevaluable balanced across groups
Selective reporting (reporting bias) Low risk Published report included all pre‐specified outcomes
Other bias Low risk No hint at any other possible biases