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

Weiss 1992.

Methods Randomised Phase II
Participants 44 women with persistent, recurrent or metastatic Squamous cell cancer cervix
1987 to 1990
Interventions Arm 1: didemnin B 2.6‐3.5 mg/m2 iv over 30 minutes d1 q28 (subsequent dose escalations if no toxicity)
Arm 2: trimetrexate 8 mg/m2 if previous radiotherapy or 12 mg/m2 if no radiotherapy iv over 10 minutes d1‐5 q21 (dose escalations to 15 mg/m2 and 18 mg/m2 respectively permitted on subsequent cycles if no toxicity)
Outcomes Overall response rate
Notes 0% response rate in either arm at any dose
1 patient ineligible as baseline imaging not done within 14 days of starting treatment
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not documented
Allocation concealment (selection bias) Unclear risk Not documented
Blinding (performance bias and detection bias) 
 All outcomes High risk Not documented
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data
Selective reporting (reporting bias) Low risk Published report included all pre‐specified outcomes  
Other bias Low risk No hint at any other possible biases

d: day; h: hour; GOG: Gynecologic Oncology Group; im: intramuscular; ITT: intention to treat; iv: intravenous; OS: overall survival; po: orally; QoL: quality of life; SWOG: Southwest Oncology Group; MVAC: methotrexate/vinblastine/doxorubicin/cisplatin; WHO: World Health Organization.