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. 2012 Sep 12;2012(9):CD009045. doi: 10.1002/14651858.CD009045.pub2

Rummel 2010.

Methods Allocation generation: not reported 
 Allocation concealment: not reported 
 Blinding: no 
 ITT: no 
 Number of dropouts: 11/219 
 Median follow‐up: 33 months
Participants 219 randomised, 208 evaluable, adult patients 
 Type of lymphoma: follicular lymphoma, mantle cell lymphoma, lymphoplasmacytic lymphoma, other indolent lymphoma 
 Stage: 93% of patients allocated to bendamustine and 86% allocated to fludarabine stage III/IV
Previous treatment: yes
Mean age: 68 years (range 38 to 87 years)
Interventions Investigational intervention:
Bendamustine 90 mg/m2 on days 1 to 2, and rituximab 375 mg/m2 on day 1; every 4 weeks, up to 6 cycles
Comparator intervention:
Fludarabine 25 mg/m2 on days 1 to 3 and rituximab 375 mg/m2 on day 1; every 4 weeks, up to 6 cycles
Outcomes Progression‐free survival
Overall survival
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk "219 patients ... were randomized ...11 patients were not evaluable due to protocol violations, and were not followed further"
Allocation of non‐evaluable patients is not reported
Selective reporting (reporting bias) Low risk Analyses were done as stated in protocol
Other bias Unclear risk Published as an abstract
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and personnel were not blinded to allocated treatment
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported

CHOP: cyclophosphamide, doxorubicin, vincristine, prednisone 
 CLL: chronic lymphocytic leukaemia 
 CR: complete response 
 ITT: intention‐to‐treat 
 iv: intravenous 
 PR: partial response 
 SLL: small lymphocytic lymphoma