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 |
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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 |
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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 |
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Notes | Published: journal article Triple publication: Hiddemann 1994; Hiddemann 1998 |
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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 |