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Notes | Unpublished data from authors This was a triple arm study: R‐CVP versus R‐CHOP versus R‐FM.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 |