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

Unterhalt 1996.

Methods RCT
Location: Europe, multicenter, GLGLSG study
Years: 1989 to 1995
Follow‐up: NR
Pharmaceutical sponsorship: NR
Classification system: Kiel/REAL
Central pathology: yes
Participants Number of patients randomized: 442
Number of patients analyzed: 246
Numbers of patients with FL: 200
Lymphoma: advanced‐stage FL grade 1‐2 and MCL
Line of treatment: first
Patients: median (range) age 54 years (28 to 77 years), 67% had bone marrow involvement
Interventions Different: PmM x 4‐6 cycles versus CVP x 4‐6 cycles
Outcomes Response rate
Event‐free interval measured from response to the recurrence of lymphoma or death
Toxicity
Notes Published: journal article
Triple publication: Hiddemann 1994; Hiddemann 1998
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "eligible patients underwent a central randomization procedure"
Comment: assumed proper sequence generation, since done by the GLGLSG
Allocation concealment (selection bias) Low risk Quote: "eligible patients underwent a central randomization procedure"
Comment: assumed proper allocation concealment, since done by the GLGLSG
Blinding (performance bias and detection bias) 
 All outcomes High risk Open study
Incomplete outcome data (attrition bias) 
 All outcomes High risk Out of 344 randomized FL patients, only 200 were fully evaluable for central pathology, 33 of whom withdrew early from study (reasons stated in study), leaving only 167 FL patients for analysis
Selective reporting (reporting bias) Unclear risk Protocol unavailable
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 do not believe this will introduce bias