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. 2013 Jul 7;2013(7):CD008909. doi: 10.1002/14651858.CD008909.pub2

Federico 2013.

Methods RCT
Location: Italy, multicenter
Years: recruited 2006 to 2010
Follow‐up: median 34 months
Pharmaceutical sponsorship: no
Classification system: WHO
Central pathology: only for grade 3 FL
Participants Number of patients randomized: 534
Number of patients analyzed: 504
Numbers of patients with FL: 504
Number of patients included in our analysis: 333
Lymphoma: previously untreated stage II to IV FL, grade 1 to 3a, age 18 to 75 years, ECOG 0 to 2
Line of treatment: first
Patients: median age (range) 56 years (30 to 75 years)
Interventions Same: R‐CHOP x 6 + R x 2 versus R‐CVP x 8
Note number of courses in each arm
Outcomes Time to treatment failure
Response rate
Progression‐free survival
Overall survival
Toxicity
Notes Unpublished data from authors
This was a triple arm study: R‐CVP versus R‐CHOP versus R‐FM. We extracted data for the first comparison, according to protocol
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization arm was assigned automatically by the EDC system upon verification of eligibility criteria. Arm was communicated on screen and confirmed by email to the investigator. Randomization was based on prepopulated tables that were prepared and uploaded by the IT staff on the EDC system at study start
Allocation concealment (selection bias) Low risk Randomization tables could not be accessed or modified, or both, by any investigator or study co‐ordinator
Blinding (performance bias and detection bias) 
 All outcomes High risk Open study
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data
Selective reporting (reporting bias) Low risk No change from protocol
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Open study; review authors did not believe this will introduce bias