Omura 1978.

Methods	Randomised Phase II trial
Participants	284 women with biopsy‐confirmed cancer of the genital tract not amenable to surgery or radiotherapy. 231 of these had cervical cancer. Previous chemotherapy allowed unless contained a nitrosourea
Interventions	Arm 1: CCNU (lomustine) 100 mg/m2 q6 weeks Arm 2: methyl‐CCNU 150 mg/m2 q6 weeks
Outcomes	Response rates Toxicity
Notes	82 patients with cervical cancer were ineligible or unevaluable. In the whole trial 102 patients were excluded owing to missing data in 77, chemotherapy violation in 22, clerical error in 2, and inadequate pathology material in 3. No ITT analysis was performed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	closed envelope technique
Allocation concealment (selection bias)	Low risk	closed envelope technique
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	82 patients with cervical cancer were ineligible or women not evaluable. Further 102 patients were excluded as not evaluable
Selective reporting (reporting bias)	Low risk	Published report included all pre‐specified outcomes
Other bias	High risk	102 patients of 284 not evaluable