Niederle 2012.

Methods	Allocation generation: computer generated Allocation concealment: central Blinding: no Number of dropouts: 4 not eligible/96 Median follow‐up: 36 months
Participants	92 randomised adult patients with relapsed chronic lymphocytic leukaemia requiring treatment after 1 previous systemic regimen Type of lymphoma: CLL/SLL Stage: Binet B/C Previous treatment: 1 line (refractory or relapse) Mean age: 68 years WHO Performance status: < 3
Interventions	Investigational: bendamustine 100 mg/m2 iv, day 1 + 2, q4w Comparator: fludarabine 25 mg/m2 iv, days 1 to 5, q4w
Outcomes	(Non‐inferior) progression‐free survival Overall survival
Notes	Unpublished data provided by the investigators as individual patient data
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation lists, created by a block randomisation method with variable block size
Allocation concealment (selection bias)	Low risk	Central
Incomplete outcome data (attrition bias) All outcomes	Low risk	4 randomised patients were ineligible and were not included in the analysis
Selective reporting (reporting bias)	Low risk	Analyses were done as stated in protocol
Other bias	Unclear risk	Responsible party and sponsor: WiSP Wissenschaftlicher Service Pharma GmbH
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding, open label
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding