Prados 2001.

Study characteristics
Methods	Randomised, phase III trial Treatment period: accrual and time period not described
Participants	231 people with glioblastoma (grade IV astrocytoma) randomised from a single centre in the US; median age 57 years, median baseline Karnofsky performance status 90; 59% men and 41% women
Interventions	Arm 1: accelerated fractionation: 7040 cGy in 44 fractions given twice a day Arm 2: accelerated fractionation as arm 1 + DFMO Arm 3: daily conventional fractionated radiotherapy: 5940 cGy in 180 cGy daily fractions Arm 4: daily conventional fractionated radiotherapy as arm 3 + DFMO
Outcomes	Survival (Kaplan‐Meier curve presented up to 400 weeks) Progression free survival (Kaplan‐Meier curve presented up to 250 weeks) Adverse events (time point for assessment was not described)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The allocation to treatment group was done by adaptive randomisation, balancing the groups by stratifying for known prognostic variables.
Allocation concealment (selection bias)	Low risk	Protection of treatment allocation before and until assignment was at low risk.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Lack of blinding of participants and personnel was associated with low risk of bias for the outcome of survival and unclear risk of bias for progression free survival and adverse events.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Lack of blinding for outcome assessment was associated with low risk of bias for survival and unclear risk of bias for progression free survival and adverse events.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Attrition was not described.
Selective reporting (reporting bias)	Unclear risk	Study protocol available and all of the study's prespecified (primary and secondary) outcomes that were of interest in the review were reported in the prespecified way. Adverse effects may have been prone to selective reporting. The degree in which selective reporting occurred for adverse effects was unknown.
Other bias	Low risk	Size of study bias: 231 randomised.