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

Herold 2006.

Methods Allocation generation: unclear 
 Allocation concealment: unclear 
 Blinding: no 
 ITT: no 
 Number of dropouts: 2/164 
 Median follow‐up: 44 months
Participants 164 randomised, 162 evaluable, adult patients 
 Type of lymphoma: follicular, mantle cell, lymphoplasmacytic lymphoma 
 Stage: III/IV
Previous treatment: no
Mean age: 58 years
WHO Performance status: < 2
Interventions Investigational intervention:
Bendamustine 60 mg/m2 on days 1 to 5, vincristine 2 mg on day 1 and prednisone 100 mg/m2 on days 1 to 5; every 3 weeks, for 8 cycles
Comparator intervention:
Cyclophosphamide 400 mg/m2 on days 1 to 5, vincristine 2 mg on day 1 and prednisone 100 mg/m2 on days 1 to 5; every 3 weeks, for 8 cycles
Outcomes Survival time was defined as time from the start of therapy until death
Time to progression was defined as the time from the start of therapy until progression or disease‐related death, and was reported in responding patients
Time to treatment failure was defined as the time from the start of therapy until treatment failure (objective progression, change of randomised therapy, intolerable toxicity or death for any reason). Rates of treatment failure in each group are described, but time to treatment failure is reported only in responding patients
CR, PR
Adverse events
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 2 patients (1%) were not evaluable and not included in the analysis. Reasons and allocation were not specified
Selective reporting (reporting bias) Unclear risk The trial's protocol was not available to evaluate selective reporting
Time to progression and time to treatment failure were reported only in responding patients
Other bias Unclear risk Funded by Ribosepharm GmbH, Clinical Research, Munich
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